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Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

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ClinicalTrials.gov Identifier: NCT00310375
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : November 25, 2016
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Enrollment 181
Recruitment Details Eligible Participants (Par) who completed the Maintenance and Transition Phases of the parent study were enrolled in this open-label extension study. Par received 600-1200 mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.
Pre-assignment Details All participants who completed Study VRX-RET-E22-301(parent study) and did not have an ongoing serious adverse event (SAE) were eligible to participate in the study.
Arm/Group Title Placebo in Parent Study Retigabine in Parent Study Safety Follow-up Continuation Phase (SFUCP)
Hide Arm/Group Description Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm. Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm. Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Period Title: Primary Reporting Phase
Started 102 79 0
Completed 11 11 0
Not Completed 91 68 0
Reason Not Completed
Adverse Event             28             22             0
Lack of Efficacy             24             19             0
Pregnancy             2             2             0
Withdrawal by Subject             10             7             0
Protocol Violation             8             5             0
Change in Par medical condition             2             0             0
Transaminase >5 upper limit of normal             2             1             0
Physician Decision             5             3             0
Request of the sponsor             2             2             0
Failed to return             1             3             0
Participant request unrelated to study             1             2             0
Going for temporal lobectomy             1             0             0
Missed study drug >5 days             1             0             0
Site closure             3             0             0
Missed study drug for 2 months             1             0             0
Par. switched to commercial product             0             1             0
Request of Ethics Committee             0             1             0
Period Title: Safety Follow-up Continuation Phase
Started 0 0 19
Completed 0 0 18 [1]
Not Completed 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             1
[1]
Met the protocol defined stopping criteria
Arm/Group Title Placebo in Parent Study Retigabine in Parent Study Total
Hide Arm/Group Description Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm. Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm. Total of all reporting groups
Overall Number of Baseline Participants 102 79 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 79 participants 181 participants
38.0  (11.74) 37.1  (12.20) 37.6  (11.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 79 participants 181 participants
Female
55
  53.9%
39
  49.4%
94
  51.9%
Male
47
  46.1%
40
  50.6%
87
  48.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 79 participants 181 participants
Caucasian 54 40 94
Hispanic 30 26 56
African-American (black) 7 7 14
Other 11 6 17
Number of Participants with Vagal nerve stimulator (VNS) use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 79 participants 181 participants
No 89 74 163
Yes 13 5 18
Number of background AEDs  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 79 participants 181 participants
AED=1 12 18 30
AED=2 47 41 88
AED=3 43 20 63
Mean Duration of Partial seizures   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 79 participants 181 participants
24.1  (13.06) 23.7  (12.88) 23.9  (12.95)
[1]
Measure Description: For this study specific outcome measure, Placebo in Parent Study N=101 and Retigabine in parent study N=79
Mean Duration of Generalized Seizure   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 79 participants 181 participants
18.6  (12.45) 25.8  (13.25) 21.5  (12.94)
[1]
Measure Description: For this study specific outcome measure, Placebo in Parent Study N=12 and Retigabine in parent study N=8
Clinical Global Impression (CGI) at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 79 participants 181 participants
Not Assessed 0 0 0
No Seizures 0 0 0
Very Mild Severity 2 0 2
Mild Severity 9 8 17
Moderate Severity 49 40 89
Marked Severity 36 26 62
Very Severe 6 5 11
Among the Most Extremely Severe 0 0 0
1.Primary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time Frame Assessed up to a maximum of 9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who took at least 1 dose of study medication
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants
Any Treatment-emergent SAE 48
Any Treatment-emergent AE 173
2.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug
Hide Description Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time Frame Assessed up to a maximum of 9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants.
52
3.Primary Outcome
Title Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Hide Description The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn’t switch to commercial product were counted as “events”. Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).
Time Frame Assessed up to a maximum of 9 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Percentage Probability of d/c
Day 0,n= 181 0.0
Day 2,n= 180 0.6
Day 6,n= 179 1.1
Day 8,n= 178 1.7
Day 12,n= 177 2.2
Day 13,n= 176 2.8
Day 18,n= 175 3.3
Day 20,n= 174 3.9
Day 21,n= 173 4.4
Day 26,n= 172 5.0
Day 27,n= 170 6.1
Day 28,n= 169 6.6
Day 29,n= 168 7.2
Day 30,n= 167 7.7
Day 32,n= 166 8.3
Day 33,n= 164 9.4
Day 39,n= 163 9.9
Day 50,n= 162 10.5
Day 52,n= 161 11.0
Day 55,n= 160 11.6
Day 67,n= 158 12.7
Day 85,n= 157 13.3
Day 89,n= 155 14.4
Day 91,n= 153 15.5
Day 93,n= 152 16.0
Day 96,n= 151 16.6
Day 109,n= 150 17.1
Day 118,n= 149 17.7
Day 119,n= 148 18.2
Day 124,n= 147 18.8
Day 134,n= 146 19.3
Day 135,n= 145 19.9
Day 140,n= 144 20.4
Day 144,n= 143 21.0
Day 166,n= 142 21.5
Day 167,n= 141 22.1
Day 175,n= 140 22.7
Day 179,n= 139 23.2
Day 180,n= 138 23.8
Day 181,n= 137 24.3
Day 182,n= 135 25.4
Day 185,n= 134 26.0
Day 188,n= 133 26.5
Day 207,n= 132 27.1
Day 210,n= 131 27.6
Day 211,n= 130 28.2
Day 213,n= 129 28.7
Day 216,n= 128 29.3
Day 224,n= 127 29.8
Day 231,n= 126 30.4
Day 237,n= 125 30.9
Day 240,n= 124 31.5
Day 253,n= 123 32.0
Day 271,n= 122 32.6
Day 278,n= 121 33.1
Day 280,n= 120 33.7
Day 281,n= 119 34.3
Day 282,n= 118 34.8
Day 303,n= 117 35.4
Day 315,n= 116 35.9
Day 336,n= 114 37.0
Day 338,n= 113 37.6
Day 358,n= 112 38.1
Day 361,n= 111 38.7
Day 362,n= 110 39.2
Day 372,n= 109 39.8
Day 377,n= 108 40.3
Day 392,n= 107 40.9
Day 407,n= 106 41.4
Day 413,n= 105 42.0
Day 477,n= 104 42.5
Day 479,n= 103 43.1
Day 483,n= 102 43.6
Day 489,n= 101 44.2
Day 535,n= 100 44.8
Day 593,n= 99 45.3
Day 602,n= 98 45.9
Day 603,n= 97 46.4
Day 606,n= 96 47.0
Day 609,n= 95 47.5
Day 660,n= 94 48.1
Day 685,n= 93 48.6
Day 722,n= 92 49.2
Day 783,n= 91 49.7
Day 821,n= 90 50.3
Day 843,n= 88 51.4
Day 848,n= 87 51.9
Day 881,n= 86 52.5
Day 959,n= 85 53.0
Day 1076,n= 84 53.6
Day 1080,n= 83 54.1
Day 1084,n= 82 54.7
Day 1090,n= 81 55.2
Day 1119,n= 80 55.8
Day 1146,n= 79 56.4
Day 1196,n= 78 56.9
Day 1210,n= 77 57.5
Day 1225,n= 76 58.0
Day 1322,n= 75 58.6
Day 1326,n= 74 59.1
Day 1338,n= 73 59.7
Day 1339,n= 72 60.2
Day 1407,n= 71 60.8
Day 1429,n= 70 61.3
Day 1520,n= 69 61.9
Day 1561,n= 68 62.4
Day 1563,n= 67 63.0
Day 1619,n= 66 63.0
Day 1645,n= 65 63.0
Day 1655,n= 64 63.0
Day 1656,n= 63 63.0
Day 1673,n= 62 63.6
Day 1676,n= 61 64.2
Day 1686,n= 60 64.7
Day 1737,n= 59 64.7
Day 1780,n= 58 64.7
Day 1800,n= 57 65.4
Day 1811,n= 56 66.0
Day 1813,n= 55 66.6
Day 1862,n= 54 66.6
Day 1885,n= 53 67.2
Day 1911,n= 52 67.2
Day 1926,n= 51 67.2
Day 1933,n= 50 67.2
Day 1952,n= 49 67.8
Day 1989,n= 48 67.8
Day 1994,n= 47 68.5
Day 2008,n= 46 68.5
Day 2038,n= 45 68.5
Day 2044,n= 44 69.2
Day 2051,n= 43 69.9
Day 2073,n= 42 69.9
Day 2109,n= 41 69.9
Day 2111,n= 40 69.9
Day 2139,n= 39 69.9
Day 2157,n= 38 69.9
Day 2161,n= 37 70.7
Day 2164,n= 36 71.5
Day 2170,n= 35 72.3
Day 2228,n= 34 72.3
Day 2234,n= 33 72.3
Day 2248,n= 32 72.3
Day 2274,n= 31 73.2
Day 2278,n= 30 73.2
Day 2282,n= 28 74.9
Day 2290,n= 27 75.8
Day 2294,n= 26 76.7
Day 2297,n= 25 77.6
Day 2301,n= 24 78.5
Day 2337,n= 23 79.4
Day 2393,n= 22 80.3
Day 2523,n= 21 81.2
Day 2527,n= 20 82.1
Day 2528,n= 19 83.0
Day 2535,n= 18 83.9
Day 2646,n= 16 85.7
Day 2702,n= 15 86.6
Day 2735,n= 14 87.5
Day 2768,n= 13 88.4
Day 2792,n= 12 89.3
Day 2795,n= 11 90.2
Day 2833,n= 10 91.1
Day 2848,n= 9 91.9
Day 2871,n= 8 92.8
Day 2886,n= 7 93.7
Day 3001,n= 6 94.6
Day 3004,n= 5 95.5
Day 3023,n= 4 96.4
Day 3091,n= 3 97.3
Day 3092,n= 2 98.2
Day 3101,n= 1 99.1
Day 3186,n= 0 100.0
4.Primary Outcome
Title Change From Baseline in Blood Pressure
Hide Description Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury (mmHg)
Su DBP Mon 1, n=173 -1.1  (9.74)
Su DBP Mon 3, n=159 -0.7  (9.73)
Su DBP Mon 6, n=143 -2.9  (10.61)
Su DBP Mon 9, n=125 -2.6  (10.72)
Su DBP Mon 12, n=173 -0.6  (11.08)
Su DBP Mon 16, n=104 -2.3  (11.69)
Su DBP Mon 20, n=100 -1.9  (13.12)
Su DBP Mon 24, n=112 -1.3  (11.24)
Su DBP Mon 28, n=88 -0.8  (12.75)
Su DBP Mon 32, n=85 -0.6  (11.18)
Su DBP Mon 36, n=92 -1.6  (10.81)
Su DBP Mon 40, n=78 -2.5  (11.62)
Su DBP Mon 44, n=76 -1.1  (11.75)
Su DBP Mon 48, n=82 -1.2  (11.76)
Su DBP Mon 52, n=68 0.7  (9.74)
Su DBP Mon 56, n=63 -0.3  (11.37)
Su DBP Mon 60, n=70 -0.8  (11.67)
Su DBP Mon 64, n=50 -1.7  (11.34)
Su DBP Mon 68, n=45 -1.1  (11.24)
Su DBP Mon 72, n=57 0.2  (11.02)
Su DBP Mon 76, n=31 -0.5  (9.01)
Su DBP Mon 80, n=24 -1  (7.13)
Su DBP Mon 84, n=36 -2.3  (11.04)
Su DBP Mon 88, n=17 -0.1  (6.94)
Su DBP Mon 92, n=16 -2.8  (8.49)
Su DBP Mon 96, n=19 -0.2  (8.3)
Su DBP Mon 100, n=7 -6.3  (3.25)
Su DBP Mon 104, n=1 -20.0 [1]   (NA)
Su DBP Mon 108, n=10 -2.0  (7.27)
St DBP Mon 1, n=173 -0.5  (9.97)
St DBP Mon 3, n=159 -1.0  (11.68)
St DBP Mon 6, n=143 -1.8  (11.47)
St DBP Mon 9, n=125 -1.9  (10.17)
St DBP Mon 12, n=170 -1.0  (11.18)
St DBP Mon 16, n=104 -1.8  (11.14)
St DBP Mon 20, n=100 -1.0  (12.02)
St DBP Mon 24, n=110 0.5  (11.78)
St DBP Mon 28, n=87 -1.0  (12.83)
St DBP Mon 32, n=84 0.9  (11.95)
St DBP Mon 36, n=91 -0.7  (10.78)
St DBP Mon 40, n=77 -0.6  (11.09)
St DBP Mon 44, n=75 -0.6  (11.67)
St DBP Mon 48, n=81 0.1  (11.74)
St DBP Mon 52, n=67 1.0  (11.49)
St DBP Mon 56, n=62 -1.0  (11.2)
St DBP Mon 60, n=69 -1.9  (14.12)
St DBP Mon 64, n=49 -2.1  (11.94)
St DBP Mon 68, n=45 -2.9  (11.91)
St DBP Mon 72, n=56 0.5  (11.13)
St DBP Mon 76, n=30 -2.4  (13.08)
St DBP Mon 80, n=23 -2.0  (10.86)
St DBP Mon 84, n=34 -0.6  (12.17)
St DBP Mon 88, n=17 0.6  (8.99)
St DBP Mon 92, n=16 -3.1  (9.84)
St DBP Mon 96, n=19 2.3  (8.81)
St DBP Mon 100, n=7 -4.9  (4.41)
St DBP Mon 104, n=1 -20.0 [1]   (NA)
St DBP Mon 108, n=10 -4.5  (5.46)
Su SBP Mon 1, n=173 -1.1  (14.70)
Su SBP Mon 3, n=159 0.3  (12.96)
Su SBP Mon 6, n=143 -0.7  (14.78)
Su SBP Mon 9, n=125 -0.4  (14.14)
Su SBP Mon 12, n=173 0.4  (15.70)
Su SBP Mon 16, n=104 -2.2  (15.08)
Su SBP Mon 20, n=100 -0.7  (15.62)
Su SBP Mon 24, n=112 0.5  (16.11)
Su SBP Mon 28, n=88 -0.1  (16.06)
Su SBP Mon 32, n=85 0.3  (16.57)
Su SBP Mon 36, n=92 0.3  (15.78)
Su SBP Mon 40, n=78 -0.8  (15.08)
Su SBP Mon 44, n=76 0.3  (16.62)
Su SBP Mon 48, n=82 2.6  (15.99)
Su SBP Mon 52, n=68 3.3  (15.32)
Su SBP Mon 56, n=63 1.3  (15.30)
Su SBP Mon 60, n=70 0.7  (13.57)
Su SBP Mon 64, n=50 0.1  (18.76)
Su SBP Mon 68, n=45 -0.2  (18.29)
Su SBP Mon 72, n=57 0.8  (17.21)
Su SBP Mon 76, n=31 -1.2  (17.42)
Su SBP Mon 80, n=24 -2.6  (12.80)
Su SBP Mon 84, n=36 -3.0  (18.16)
Su SBP Mon 88, n=17 0.6  (12.07)
Su SBP Mon 92, n=16 -0.9  (17.07)
Su SBP Mon 96, n=19 -0.9  (12.33)
Su SBP Mon 100, n=7 -3.6  (9.95)
Su SBP Mon 104, n=1 -20.0 [1]   (NA)
Su SBP Mon 108, n=10 -4.4  (16.60)
St SBP Mon 1, n=173 0.3  (14.10)
St SBP Mon 3, n=159 -1.6  (15.38)
St SBP Mon 6, n=143 0.1  (14.35)
St SBP Mon 9, n=125 0.2  (14.84)
St SBP Mon 12, n=170 1.4  (15.25)
St SBP Mon 16, n=104 0.1  (14.69)
St SBP Mon 20, n=100 2.1  (16.05)
St SBP Mon 24, n=110 3.8  (17.42)
St SBP Mon 28, n=87 1.6  (15.53)
St SBP Mon 32, n=84 3.1  (17.06)
St SBP Mon 36, n=91 1.7  (15.20)
St SBP Mon 40, n=77 1.7  (16.79)
St SBP Mon 44, n=75 2.7  (15.80)
St SBP Mon 48, n=81 3.3  (14.51)
St SBP Mon 52, n=67 3.9  (18.37)
St SBP Mon 56, n=62 2.7  (13.99)
St SBP Mon 60, n=69 2.1  (13.41)
St SBP Mon 64, n=49 2.4  (17.27)
St SBP Mon 68, n=45 -0.3  (15.98)
St SBP Mon 72, n=56 2.3  (17.23)
St SBP Mon 76, n=30 -4.5  (17.63)
St SBP Mon 80, n=23 -1.1  (13.70)
St SBP Mon 84, n=34 -1.9  (13.46)
St SBP Mon 88, n=17 2.1  (11.89)
St SBP Mon 92, n=16 -4.9  (14.38)
St SBP Mon 96, n=19 0.5  (12.24)
St SBP Mon 100, n=7 -4.6  (11.16)
St SBP Mon 104, n=1 -22.0 [1]   (NA)
St SBP Mon 108, n=10 -5.5  (7.14)
[1]
Standard deviation value was not available as only one participant was analyzed
5.Primary Outcome
Title Change From Baseline in Heart Rate
Hide Description Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Beats per Minute
Su HR Mon 1, n=174 -1.0  (10.21)
Su HR Mon 3, n=159 -0.7  (11.34)
Su HR Mon 6, n=143 -0.2  (11.57)
Su HR Mon 9, n=124 -1.0  (11.33)
Su HR Mon 12, n=173 -0.1  (12.02)
Su HR Mon 16, n=104 1.1  (12.51)
Su HR Mon 20, n=100 1.1  (12.10)
Su HR Mon 24, n=112 -0.1  (15.92)
Su HR Mon 28, n=88 -0.8  (13.11)
Su HR Mon 32, n=85 0.4  (12.56)
Su HR Mon 36, n=92 -1.7  (11.38)
Su HR Mon 40, n=78 -0.6  (13.28)
Su HR Mon 44, n=76 -2.8  (12.47)
Su HR Mon 48, n=82 -2.1  (11.25)
Su HR Mon 52, n=67 -1.5  (11.39)
Su HR Mon 56, n=63 -1.8  (12.30)
Su HR Mon 60, n=70 -1.2  (12.89)
Su HR Mon 64, n=50 -2.1  (11.54)
Su HR Mon 68, n=45 1.2  (13.87)
Su HR Mon 72, n=57 -1.9  (12.32)
Su HR Mon 76, n=31 -1.6  (13.05)
Su HR Mon 80, n=24 -2.2  (11.93)
Su HR Mon 84, n=36 -2.4  (12.56)
Su HR Mon 88, n=17 1.5  (13.98)
Su HR Mon 92, n=16 -2.7  (11.52)
Su HR Mon 96, n=19 -1.0  (14.35)
Su HR Mon 100, n=7 -8.3  (19.10)
Su HR Mon 104, n=1 -6.0 [1]   (NA)
Su HR Mon 108, n=10 -3.4  (12.86)
St HR Mon 1, n=174 0.7  (11.97)
St HR Mon 3, n=158 1.0  (12.02)
St HR Mon 6, n=143 1.6  (12.82)
St HR Mon 9, n=124 1.1  (12.99)
St HR Mon 12, n=170 2.3  (12.64)
St HR Mon 16, n=104 2.5  (12.71)
St HR Mon 20, n=100 0.2  (13.35)
St HR Mon 24, n=110 2.6  (17.38)
St HR Mon 28, n=87 -0.8  (13.79)
St HR Mon 32, n=84 1.7  (11.71)
St HR Mon 36, n=91 -0.4  (12.40)
St HR Mon 40, n=77 0.4  (11.51)
St HR Mon 44, n=75 -0.3  (12.74)
St HR Mon 48, n=81 -1.9  (12.57)
St HR Mon 52, n=67 -0.3  (12.71)
St HR Mon 56, n=62 1.3  (12.21)
St HR Mon 60, n=69 -0.2  (14.44)
St HR Mon 64, n=49 1.3  (14.29)
St HR Mon 68, n=45 4.1  (14.77)
St HR Mon 72, n=56 0.4  (12.10)
St HR Mon 76, n=30 1.9  (13.26)
St HR Mon 80, n=23 3.0  (11.81)
St HR Mon 84, n=35 0.2  (13.24)
St HR Mon 88, n=17 3.6  (12.24)
St HR Mon 92, n=16 3.1  (10.13)
St HR Mon 96, n=19 3.2  (13.12)
St HR Mon 100, n=7 2.6  (10.72)
St HR Mon 104, n=1 0.0 [1]   (NA)
St HR Mon 108, n=10 -5.4  (11.37)
[1]
Standard Deviation value was not available as only one participant was analyzed
6.Primary Outcome
Title Change From Baseline in Body Temperature
Hide Description Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
Temperature, Mon 1, n=174 -0.04  (0.437)
Temperature, Mon 3, n=158 -0.08  (0.460)
Temperature, Mon 6, n=142 -0.05  (0.455)
Temperature, Mon 9, n=124 -0.06  (0.479)
Temperature, Mon 12, n=172 -0.07  (0.489)
Temperature, Mon 16, n=102 -0.01  (0.477)
Temperature, Mon 20, n=98 -0.00  (0.495)
Temperature, Mon 24, n=110 -0.07  (0.532)
Temperature, Mon 28, n=86 -0.08  (0.457)
Temperature, Mon 32, n=85 -0.09  (0.456)
Temperature, Mon 36, n=92 -0.13  (0.543)
Temperature, Mon 40, n=77 -0.12  (0.492)
Temperature, Mon 44, n=76 -0.07  (0.523)
Temperature, Mon 48, n=82 -0.06  (0.525)
Temperature, Mon 52, n=68 -0.13  (0.439)
Temperature, Mon 56, n=63 -0.09  (0.566)
Temperature, Mon 60, n=70 -0.02  (0.436)
Temperature, Mon 64, n=48 -0.12  (0.451)
Temperature, Mon 68, n=45 -0.01  (0.497)
Temperature, Mon 72, n=57 -0.06  (0.433)
Temperature, Mon 76, n=31 -0.04  (0.506)
Temperature, Mon 80, n=24 -0.08  (0.472)
Temperature, Mon 84, n=36 -0.19  (0.481)
Temperature, Mon 88, n=17 -0.20  (0.496)
Temperature, Mon 92, n=16 -0.14  (0.542)
Temperature, Mon 96, n=19 -0.26  (0.512)
Temperature, Mon 100, n=7 -0.14  (0.690)
Temperature, Mon 104, n=1 1.00 [1]   (NA)
Temperature, Mon 108, n=10 -0.15  (0.645)
[1]
Standard Deviation value was not available as only one participant was analyzed
7.Primary Outcome
Title Change From Baseline in Weight
Hide Description Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Kilograms
Weight, Mon 1, n=172 1.94  (3.691)
Weight, Mon 3, n=159 1.85  (6.455)
Weight, Mon 6, n=143 1.68  (5.315)
Weight, Mon 9, n=123 1.57  (6.149)
Weight, Mon 12, n=171 1.31  (6.961)
Weight, Mon 16, n=104 2.17  (8.799)
Weight, Mon 20, n=101 1.62  (7.786)
Weight, Mon 24, n=111 1.21  (8.178)
Weight, Mon 28, n=88 0.35  (8.859)
Weight, Mon 32, n=85 0.07  (9.084)
Weight, Mon 36, n=92 0.61  (8.066)
Weight, Mon 40, n=78 0.84  (9.106)
Weight, Mon 44, n=76 0.88  (8.137)
Weight, Mon 48, n=82 0.73  (9.097)
Weight, Mon 52, n=68 1.10  (9.401)
Weight, Mon 56, n=62 1.28  (8.998)
Weight, Mon 60, n=69 0.94  (9.335)
Weight, Mon 64, n=49 2.13  (10.004)
Weight, Mon 68, n=44 2.77  (9.79)
Weight, Mon 72, n=57 0.85  (10.701)
Weight, Mon 76, n=31 3.30  (8.260)
Weight, Mon 80, n=24 1.48  (7.899)
Weight, Mon 84, n=36 2.47  (10.022)
Weight, Mon 88, n=17 1.45  (9.036)
Weight, Mon 92, n=16 1.64  (7.571)
Weight, Mon 96, n=19 0.48  (9.380)
Weight, Mon 100, n=7 4.31  (7.006)
Weight, Mon 104, n=1 2.10 [1]   (NA)
Weight, Mon 108, n=10 3.18  (5.743)
[1]
Standard Deviation value was not available as only one participant was analyzed
8.Primary Outcome
Title Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)
Hide Description A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Milliseconds (msec)
QTcB, Mon 1, n=172 3.3  (18.13)
QTcB, Mon 3, n=157 5.8  (18.84)
QTcB, Mon 6, n=139 1.5  (17.29)
QTcB, Mon 9, n=121 2.2  (17.18)
QTcB, Mon 12, n=168 5.7  (19.18)
QTcB, Mon 24, n=109 5.9  (18.52)
QTcB, Mon 36, n=89 3.7  (20.32)
QTcB, Mon 48, n=80 5.4  (17.74)
QTcB, Mon 60, n=70 5.1  (17.76)
QTcB, Mon 72, n=54 5.5  (15.86)
QTcB, Mon 84, n=36 8.1  (16.02)
QTcB, Mon 96, n=19 11.0  (15.95)
QTcB, Mon 108, n=10 -3.7  (17.25)
QTcF, Mon 1, n=172 4.7  (16.12)
QTcF, Mon 3, n=157 6.0  (16.57)
QTcF, Mon 6, n=139 1.4  (15.79)
QTcF, Mon 9, n=121 2.9  (15.57)
QTcF, Mon 12, n=168 5.5  (16.51)
QTcF, Mon 24, n=109 4.7  (15.91)
QTcF, Mon 36, n=89 4.3  (16.58)
QTcF, Mon 48, n=80 5.9  (14.93)
QTcF, Mon 60, n=70 5.9  (13.94)
QTcF, Mon 72, n=54 7.2  (16.89)
QTcF, Mon 84, n=36 9.3  (14.20)
QTcF, Mon 96, n=19 8.9  (14.83)
QTcF, Mon 108, n=10 -5.7  (12.64)
PR interval, Mon 1, n=173 -0.8  (13.07)
PR interval, Mon 3, n=158 1.0  (12.99)
PR interval, Mon 6, n=139 0.0  (12.69)
PR interval, Mon 9, n=123 -1.4  (12.44)
PR interval, Mon 12, n=168 -1.0  (12.61)
PR interval, Mon 24, n=110 -3.1  (12.16)
PR interval, Mon 36, n=89 -0.3  (11.39)
PR interval, Mon 48, n=80 0.3  (16.32)
PR interval, Mon 60, n=71 2.5  (14.12)
PR interval, Mon 72, n=53 2.2  (11.71)
PR interval, Mon 84, n=36 4.3  (9.34)
PR interval, Mon 96, n=19 -2.4  (13)
PR interval, Mon 108, n=10 0.0  (15.5)
QRS duration, Mon 1, n=174 0.4  (7.37)
QRS duration, Mon 3, n=159 -0.2  (7.64)
QRS duration, Mon 6, n=142 -0.2  (7.05)
QRS duration, Mon 9, n=124 0.4  (8.04)
QRS duration, Mon 12, n=171 -0.0  (9.4)
QRS duration, Mon 24, n=112 0.7  (8.56)
QRS duration, Mon 36, n=90 1.6  (7.31)
QRS duration, Mon 48, n=81 4.0  (7.82)
QRS duration, Mon 60, n=70 3.9  (8.19)
QRS duration, Mon 72, n=55 6.2  (9.15)
QRS duration, Mon 84, n=36 4.2  (7.94)
QRS duration, Mon 96, n=19 3.8  (7.21)
QRS duration, Mon 108, n=10 3.7  (9.4)
uQT, Mon 1, n=172 7.5  (22.93)
uQT, Mon 3, n=157 6.4  (25.31)
uQT, Mon 6, n=139 1.4  (25.95)
uQT, Mon 9, n=121 4.3  (25.00)
uQT, Mon 12, n=168 5.1  (24.70)
uQT, Mon 24, n=109 2.8  (23.97)
uQT, Mon 36, n=89 5.5  (22.57)
uQT, Mon 48, n=80 7.2  (22.42)
uQT, Mon 60, n=70 7.3  (24.74)
uQT, Mon 72, n=54 11.0  (28.33)
uQT, Mon 84, n=36 12.5  (26.56)
uQT, Mon 96, n=19 5.4  (26.73)
uQT, Mon 108, n=10 -8.7  (14.01)
9.Primary Outcome
Title Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval
Hide Description A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Seconds (sec)
RR interval, Mon 1, n=174 0.0195  (0.11576)
RR interval, Mon 3, n=159 0.0029  (0.12883)
RR interval, Mon 6, n=142 -0.0007  (0.13151)
RR interval, Mon 9, n=124 0.0103  (0.12659)
RR interval, Mon 12, n=172 -0.0015  (0.12556)
RR interval, Mon 24, n=112 -0.0119  (0.1206)
RR interval, Mon 36, n=92 0.0144  (0.12476)
RR interval, Mon 48, n=81 0.0145  (0.12175)
RR interval, Mon 60, n=71 0.0098  (0.14452)
RR interval, Mon 72, n=55 0.0251  (0.12713)
RR interval, Mon 84, n=36 0.0285  (0.15006)
RR interval, Mon 96, n=19 -0.0237  (0.1485)
RR interval, Mon 108, n=10 -0.0173  (0.10885)
10.Primary Outcome
Title Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
Hide Description A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Degree
QRS axis, Mon 1, n=167 -1.3  (14.34)
QRS axis, Mon 3, n=151 -2.9  (15.94)
QRS axis, Mon 6, n=134 -1.5  (11.50)
QRS axis, Mon 9, n=118 -2.3  (11.8)
QRS axis, Mon 12, n=160 -3.1  (13.72)
QRS axis, Mon 24, n=104 -1.9  (13.03)
QRS axis, Mon 36, n=87 -2.5  (11.43)
QRS axis, Mon 48, n=77 -3.4  (19.82)
QRS axis, Mon 60, n=68 -8.0  (14.50)
QRS axis, Mon 72, n=52 -4.0  (12.31)
QRS axis, Mon 84, n=34 -4.1  (16.09)
QRS axis, Mon 96, n=18 -4.9  (8.53)
QRS axis, Mon 108, n=10 -7.0  (8.81)
11.Primary Outcome
Title Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)
Hide Description Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/Liter
Bands, Mon 1, n=2 -0.135  (0.1768)
Bands, Mon 9, n=2 -0.205  (0.6576)
Bands, Mon 20, n=2 -0.095  (0.1202)
Basophils, Mon 1, n=168 -0.001  (0.0270)
Basophils, Mon 2, n=15 -0.015  (0.0307)
Basophils, Mon 3, n=153 0.001  (0.0274)
Basophils, Mon 4, n=26 -0.002  (0.0199)
Basophils, Mon 6, n=137 0.004  (0.0245)
Basophils, Mon 8, n=42 0.002  (0.0258)
Basophils, Mon 9, n=121 0.003  (0.0274)
Basophils, Mon 10, n=54 0.001  (0.0241)
Basophils, Mon 12, n=165 0.001  (0.0298)
Basophils, Mon 16, n=96 0.005  (0.0288)
Basophils, Mon 20, n=92 0.004  (0.0271)
Basophils, Mon 24, n=109 0.008  (0.0289)
Basophils, Mon 28, n=84 0.005  (0.0289)
Basophils, Mon 32, n=81 0.005  (0.0301)
Basophils, Mon 36, n=91 0.006  (0.0295)
Basophils, Mon 40, n=74 0.004  (0.0243)
Basophils, Mon 44, n=72 0.004  (0.0200)
Basophils, Mon 48, n=77 0.004  (0.0313)
Basophils, Mon 52, n=65 -0.004  (0.0227)
Basophils, Mon 56, n=63 -0.004  (0.0234)
Basophils, Mon 60, n=71 -0.003  (0.0238)
Basophils, Mon 64, n=49 -0.003  (0.0195)
Basophils, Mon 68, n=43 0.001  (0.0197)
Basophils, Mon 72, n=53 -0.003  (0.0227)
Basophils, Mon 76, n=31 -0.000  (0.0218)
Basophils, Mon 80, n=24 -0.001  (0.0198)
Basophils, Mon 84, n=33 0.002  (0.0238)
Basophils, Mon 88, n=16 0.003  (0.0202)
Basophils, Mon 92, n=15 0.005  (0.0288)
Basophils, Mon 96, n=19 0.006  (0.0257)
Basophils, Mon 100, n=7 0.021  (0.0157)
Basophils, Mon 104, n=1 -0.020 [1]   (NA)
Basophils, Mon 108, n=10 0.012  (0.0210)
Eosinophils, Mon 1, n=168 -0.008  (0.1009)
Eosinophils, Mon 2, n=15 0.023  (0.0948)
Eosinophils, Mon 3, n=153 -0.010  (0.1329)
Eosinophils, Mon 4, n=26 -0.003  (0.1236)
Eosinophils, Mon 6, n=137 -0.015  (0.1208)
Eosinophils, Mon 8, n=42 -0.022  (0.1078)
Eosinophils, Mon 9, n=121 -0.010  (0.1166)
Eosinophils, Mon 10, n=54 0.000  (0.1083)
Eosinophils, Mon 12, n=165 -0.019  (0.0943)
Eosinophils, Mon 16, n=96 -0.006  (0.1145)
Eosinophils, Mon 20, n=92 -0.009  (0.0941)
Eosinophils, Mon 24, n=109 -0.002  (0.1108)
Eosinophils, Mon 28, n=84 -0.016  (0.1114)
Eosinophils, Mon 32, n=81 0.001  (0.1192)
Eosinophils, Mon 36, n=91 -0.006  (0.1026)
Eosinophils, Mon 40, n=74 -0.004  (0.1165)
Eosinophils, Mon 44, n=72 -0.014  (0.1158)
Eosinophils, Mon 48, n=77 -0.002  (0.1230)
Eosinophils, Mon 52, n=65 -0.011  (0.1137)
Eosinophils, Mon 56, n=63 -0.002  (0.1251)
Eosinophils, Mon 60, n=71 -0.014  (0.1123)
Eosinophils, Mon 64, n=49 -0.008  (0.0989)
Eosinophils, Mon 68, n=43 -0.000  (0.1122)
Eosinophils, Mon 72, n=53 0.005  (0.1049)
Eosinophils, Mon 76, n=31 -0.003  (0.1102)
Eosinophils, Mon 80, n=24 -0.010  (0.0837)
Eosinophils, Mon 84, n=33 -0.000  (0.1105)
Eosinophils, Mon 88, n=16 0.030  (0.0602)
Eosinophils, Mon 92, n=15 0.006  (0.0631)
Eosinophils, Mon 96, n=19 0.018  (0.0511)
Eosinophils, Mon 100, n=7 0.033  (0.093)
Eosinophils, Mon 104, n=1 0.030 [1]   (NA)
Eosinophils, Mon 108, n=10 -0.005  (0.0792)
Lymphocytes, Mon 1, n=168 -0.178  (0.4512)
Lymphocytes, Mon 2, n=15 -0.043  (0.6364)
Lymphocytes, Mon 3, n=153 -0.134  (0.4336)
Lymphocytes, Mon 4, n=26 0.054  (0.3529)
Lymphocytes, Mon 6, n=137 -0.055  (0.4415)
Lymphocytes, Mon 8, n=42 0.168  (0.7157)
Lymphocytes, Mon 9, n=121 -0.031  (0.472)
Lymphocytes, Mon 10, n=54 0.120  (0.5265)
Lymphocytes, Mon 12, n=165 0.009  (0.5438)
Lymphocytes, Mon 16, n=96 -0.053  (0.5393)
Lymphocytes, Mon 20, n=92 -0.031  (0.5364)
Lymphocytes, Mon 24, n=109 -0.069  (0.4973)
Lymphocytes, Mon 28, n=84 -0.077  (0.5271)
Lymphocytes, Mon 32, n=81 0.013  (0.5920)
Lymphocytes, Mon 36, n=91 -0.055  (0.4798)
Lymphocytes, Mon 40, n=74 -0.028  (0.4699)
Lymphocytes, Mon 44, n=72 0.008  (0.4681)
Lymphocytes, Mon 48, n=77 0.061  (0.5921)
Lymphocytes, Mon 52, n=65 -0.049  (0.4875)
Lymphocytes, Mon 56, n=63 -0.065  (0.5298)
Lymphocytes, Mon 60, n=71 -0.025  (0.5503)
Lymphocytes, Mon 64, n=49 -0.011  (0.5106)
Lymphocytes, Mon 68, n=43 -0.002  (0.6027)
Lymphocytes, Mon 72, n=53 -0.052  (0.5410)
Lymphocytes, Mon 76, n=31 0.104  (0.6589)
Lymphocytes, Mon 80, n=24 0.149  (0.6626)
Lymphocytes, Mon 84, n=33 0.154  (0.6009)
Lymphocytes, Mon 88, n=16 0.189  (0.4887)
Lymphocytes, Mon 92, n=15 0.405  (0.5963)
Lymphocytes, Mon 96, n=19 0.285  (0.6170)
Lymphocytes, Mon 100, n=7 0.144  (0.4465)
Lymphocytes, Mon 104, n=1 0.000 [1]   (NA)
Lymphocytes, Mon 108, n=10 0.044  (0.5883)
Metamyelocyte, Mon 3, n=1 -0.010 [1]   (NA)
Monocytes, Mon 1, n=168 0.006  (0.1755)
Monocytes, Mon 2, n=15 0.002  (0.2583)
Monocytes, Mon 3, n=153 0.016  (0.1730)
Monocytes, Mon 4, n=26 0.039  (0.1759)
Monocytes, Mon 6, n=137 -0.001  (0.1628)
Monocytes, Mon 8, n=42 0.033  (0.2000)
Monocytes, Mon 9, n=121 -0.002  (0.1808)
Monocytes, Mon 10, n=54 0.029  (0.1686)
Monocytes, Mon 12, n=165 -0.007  (0.1724)
Monocytes, Mon 16, n=96 -0.021  (0.1651)
Monocytes, Mon 20, n=92 -0.009  (0.1573)
Monocytes, Mon 24, n=109 -0.004  (0.2189)
Monocytes, Mon 28, n=84 -0.031  (0.1759)
Monocytes, Mon 32, n=81 -0.005  (0.1673)
Monocytes, Mon 36, n=91 -0.039  (0.1821)
Monocytes, Mon 40, n=74 -0.013  (0.1718)
Monocytes, Mon 44, n=72 -0.037  (0.1807)
Monocytes, Mon 48, n=77 -0.036  (0.1869)
Monocytes, Mon 52, n=65 -0.026  (0.1743)
Monocytes, Mon 56, n=63 -0.035  (0.1776)
Monocytes, Mon 60, n=71 -0.013  (0.1720)
Monocytes, Mon 64, n=49 -0.024  (0.1486)
Monocytes, Mon 68, n=43 0.003  (0.1491)
Monocytes, Mon 72, n=53 -0.007  (0.1704)
Monocytes, Mon 76, n=31 0.038  (0.1456)
Monocytes, Mon 80, n=24 0.019  (0.1473)
Monocytes, Mon 84, n=33 0.065  (0.1555)
Monocytes, Mon 88, n=16 -0.006  (0.1699)
Monocytes, Mon 92, n=15 0.029  (0.1737)
Monocytes, Mon 96, n=19 0.035  (0.1437)
Monocytes, Mon 100, n=7 0.004  (0.1274)
Monocytes, Mon 104, n=1 0.070 [1]   (NA)
Monocytes, Mon 108, n=10 0.064  (0.2400)
Neutrophils, Mon 1, n=168 0.158  (1.5462)
Neutrophils, Mon 2, n=15 -0.500  (1.6917)
Neutrophils, Mon 3, n=153 0.211  (1.2173)
Neutrophils, Mon 4, n=26 -0.003  (1.1181)
Neutrophils, Mon 6, n=137 0.124  (1.0916)
Neutrophils, Mon 8, n=42 -0.427  (1.1287)
Neutrophils, Mon 9, n=121 0.074  (1.0966)
Neutrophils, Mon 10, n=54 0.211  (1.4455)
Neutrophils, Mon 12, n=165 0.309  (1.2657)
Neutrophils, Mon 16, n=96 0.232  (1.0227)
Neutrophils, Mon 20, n=92 0.145  (1.039)
Neutrophils, Mon 24, n=109 0.221  (1.1556)
Neutrophils, Mon 28, n=84 -0.032  (1.1173)
Neutrophils, Mon 32, n=81 -0.034  (1.1604)
Neutrophils, Mon 36, n=91 -0.054  (1.0499)
Neutrophils, Mon 40, n=74 0.141  (1.101)
Neutrophils, Mon 44, n=72 0.003  (1.0641)
Neutrophils, Mon 48, n=77 0.197  (1.4174)
Neutrophils, Mon 56, n=63 0.075  (1.069)
Neutrophils, Mon 52, n=65 0.151  (1.1449)
Neutrophils, Mon 60, n=71 0.203  (1.653)
Neutrophils, Mon 64, n=49 -0.042  (1.0603)
Neutrophils, Mon 68, n=43 0.304  (1.3417)
Neutrophils, Mon 72, n=53 0.337  (1.3877)
Neutrophils, Mon 76, n=31 0.380  (0.9556)
Neutrophils, Mon 80, n=24 0.495  (1.1337)
Neutrophils, Mon 84, n=33 0.735  (1.2746)
Neutrophils, Mon 88, n=16 0.036  (0.689)
Neutrophils, Mon 92, n=15 0.275  (1.2747)
Neutrophils, Mon 96, n=19 0.444  (1.1230)
Neutrophils, Mon 100, n=7 0.156  (0.5022)
Neutrophils, Mon 104, n=1 0.270 [1]   (NA)
Neutrophils, Mon 108, n=10 0.185  (0.9415)
Platelet Count, Mon 1, n=165 -4.1  (38.59)
Platelet Count, Mon 2, n=15 5.3  (47.49)
Platelet Count, Mon 3, n=150 -5.4  (40.70)
Platelet Count, Mon 4, n=26 -2  (54.42)
Platelet Count, Mon 6, n=131 -7  (48.59)
Platelet Count, Mon 8, n=42 6  (49.17)
Platelet Count, Mon 9, n=119 -4.7  (38.65)
Platelet Count, Mon 10, n=54 2.9  (39.60)
Platelet Count, Mon 12, n=161 -5.2  (40.72)
Platelet Count, Mon 16, n=94 -0.2  (46.65)
Platelet Count, Mon 20, n=91 -1.9  (44.44)
Platelet Count, Mon 24, n=104 -11.0  (42.31)
Platelet Count, Mon 28, n=82 -14.4  (46.60)
Platelet Count, Mon 32, n=82 -23.2  (45.64)
Platelet Count, Mon 36, n=87 -24.4  (39.19)
Platelet Count, Mon 40, n=76 -18.0  (40.84)
Platelet Count, Mon 48, n=77 -16.1  (41.68)
Platelet Count, Mon 52, n=65 -17.5  (35.27)
Platelet Count, Mon 56, n=62 -21.3  (36.88)
Platelet Count, Mon 60, n=68 -22.3  (38.07)
Platelet Count, Mon 64, n=47 -20.2  (47.45)
Platelet Count, Mon 68, n=44 -21.0  (48.34)
Platelet Count, Mon 72, n=52 -15.7  (43.17)
Platelet Count, Mon 76, n=31 -11.5  (52.19)
Platelet Count, Mon 80, n=24 -6.3  (43.84)
Platelet Count, Mon 84, n=35 -4.3  (40.03)
Platelet Count, Mon 88, n=16 -10.2  (30.96)
Platelet Count, Mon 92, n=15 -2.9  (25.92)
Platelet Count, Mon 96, n=19 -7.2  (37.84)
Platelet Count, Mon 100, n=7 -14.3  (50.43)
Platelet Count, Mon 104, n=1 -46.0 [1]   (NA)
Platelet Count, Mon 108, n=10 -22.3  (40.89)
WBC, Mon 1, n=169 -0.00  (1.708)
WBC, Mon 2, n=15 -0.53  (2.281)
WBC, Mon 3, n=154 0.10  (1.434)
WBC, Mon 4, n=26 0.17  (1.279)
WBC, Mon 6, n=137 0.06  (1.235)
WBC, Mon 8, n=43 -0.11  (1.577)
WBC, Mon 9, n=122 0.05  (1.356)
WBC, Mon 10, n=55 0.33  (1.654)
WBC, Mon 12, n=167 0.30  (1.500)
WBC, Mon 16, n=99 0.20  (1.362)
WBC, Mon 20, n=96 0.14  (1.274)
WBC, Mon 24, n=110 0.16  (1.398)
WBC, Mon 28, n=85 -0.14  (1.303)
WBC, Mon 32, n=86 0.02  (1.347)
WBC, Mon 36, n=91 -0.14  (1.233)
WBC, Mon 40, n=78 0.13  (1.331)
WBC, Mon 44, n=74 -0.04  (1.372)
WBC, Mon 48, n=79 0.24  (1.438)
WBC, Mon 52, n=68 0.09  (1.397)
WBC, Mon 56, n=63 -0.04  (1.198)
WBC, Mon 60, n=71 0.18  (1.892)
WBC, Mon 64, n=49 -0.09  (1.236)
WBC, Mon 68, n=44 0.27  (1.463)
WBC, Mon 72, n=53 0.27  (1.502)
WBC, Mon 76, n=31 0.51  (1.252)
WBC, Mon 80, n=24 0.65  (1.219)
WBC, Mon 84, n=35 0.93  (1.290)
WBC, Mon 88, n=16 0.25  (0.836)
WBC, Mon 92, n=15 0.73  (1.348)
WBC, Mon 96, n=19 0.79  (1.129)
WBC, Mon 100, n=7 0.36  (0.483)
WBC, Mon 104, n=1 0.30 [1]   (NA)
WBC, Mon 108, n=10 0.31  (0.743)
[1]
Standard deviation value was not available as only one participant was analyzed
12.Primary Outcome
Title Change From Baseline in Hematology Parameter-Red Blood Cell Count
Hide Description Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/Liter(L)
RBC, Mon 1, n=169 -0.09  (0.281)
RBC, Mon 2, n=15 0.01  (0.222)
RBC, Mon 3, n=154 -0.06  (0.309)
RBC, Mon 4, n=26 -0.16  (0.305)
RBC, Mon 6, n=137 -0.04  (0.287)
RBC, Mon 8, n=43 -0.03  (0.312)
RBC, Mon 9, n=122 -0.06  (0.294)
RBC, Mon 10, n=55 -0.01  (0.299)
RBC, Mon 12, n=167 0.00  (0.291)
RBC, Mon 16, n=99 -0.04  (0.320)
RBC, Mon 20, n=96 0.01  (0.329)
RBC, Mon 24, n=110 -0.01  (0.290)
RBC, Mon 28, n=85 -0.04  (0.324)
RBC, Mon 32, n=86 -0.03  (0.322)
RBC, Mon 36, n=91 -0.11  (0.288)
RBC, Mon 40, n=78 -0.11  (0.320)
RBC, Mon 44, n=74 -0.09  (0.318)
RBC, Mon 48, n=79 -0.16  (0.316)
RBC, Mon 52, n=68 -0.08  (0.336)
RBC, Mon 56, n=63 -0.13  (0.272)
RBC, Mon 60, n=71 -0.14  (0.317)
RBC, Mon 64, n=49 -0.10  (0.323)
RBC, Mon 68, n=44 -0.06  (0.326)
RBC, Mon 72, n=53 -0.09  (0.363)
RBC, Mon 76, n=31 0.00  (0.373)
RBC, Mon 80, n=24 -0.03  (0.343)
RBC, Mon 84, n=35 -0.00  (0.379)
RBC, Mon 88, n=16 0.03  (0.353)
RBC, Mon 92, n=15 0.14  (0.300)
RBC, Mon 96, n=19 0.04  (0.248)
RBC, Mon 100, n=7 0.23  (0.287)
RBC, Mon 104, n=1 0.30 [1]   (NA)
RBC, Mon 108, n=10 0.15  (0.207)
[1]
Standard deviation value was not available as only one participant was analyzed
13.Primary Outcome
Title Change From Baseline in Haematocrit
Hide Description Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Volume/Volume (v/v)
Haematocrit, Mon 1, n=165 -0.009  (0.0272)
Haematocrit, Mon 2, n=15 -0.001  (0.0210)
Haematocrit, Mon 3, n=153 -0.007  (0.0287)
Haematocrit, Mon 4, n=26 -0.012  (0.0293)
Haematocrit, Mon 6, n=136 -0.004  (0.0262)
Haematocrit, Mon 8, n=41 -0.005  (0.0248)
Haematocrit, Mon 9, n=120 -0.006  (0.0272)
Haematocrit, Mon 10, n=55 -0.002  (0.0295)
Haematocrit, Mon 12, n=162 -0.001  (0.0291)
Haematocrit, Mon 16, n=98 -0.005  (0.0292)
Haematocrit, Mon 20, n=94 -0.001  (0.0280)
Haematocrit, Mon 24, n=109 -0.002  (0.0267)
Haematocrit, Mon 28, n=84 -0.004  (0.0250)
Haematocrit, Mon 32, n=85 -0.001  (0.0273)
Haematocrit, Mon 36, n=91 -0.005  (0.0298)
Haematocrit, Mon 40, n=77 -0.004  (0.0319)
Haematocrit, Mon 44, n=73 -0.002  (0.0287)
Haematocrit, Mon 48, n=76 -0.009  (0.0376)
Haematocrit, Mon 52, n=67 0.001  (0.0347)
Haematocrit, Mon 56, n=62 -0.001  (0.0335)
Haematocrit, Mon 60, n=71 0.005  (0.0352)
Haematocrit, Mon 64, n=49 0.004  (0.0332)
Haematocrit, Mon 68, n=44 0.011  (0.0345)
Haematocrit, Mon 72, n=53 0.008  (0.0346)
Haematocrit, Mon 76, n=31 0.014  (0.0350)
Haematocrit, Mon 80, n=23 0.009  (0.0272)
Haematocrit, Mon 84, n=34 0.007  (0.0379)
Haematocrit, Mon 88, n=16 0.017  (0.0332)
Haematocrit, Mon 92, n=14 0.027  (0.0267)
Haematocrit, Mon 96, n=18 0.017  (0.0311)
Haematocrit, Mon 100, n=6 0.028  (0.0232)
Haematocrit, Mon 108, n=9 0.030  (0.0283)
14.Primary Outcome
Title Change From Baseline in Haemoglobin
Hide Description Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Grams/Liter (g/L)
Haemoglobin, Mon 1, n=169 -3.2  (8.97)
Haemoglobin, Mon 2, n=15 -0.9  (7.26)
Haemoglobin, Mon 3, n=154 -2.6  (9.41)
Haemoglobin, Mon 4, n=26 -5.7  (10.44)
Haemoglobin, Mon 6, n=137 -2.2  (9.31)
Haemoglobin, Mon 8, n=43 -1.9  (9.40)
Haemoglobin, Mon 9, n=122 -2.9  (9.45)
Haemoglobin, Mon 10, n=55 -0.9  (9.26)
Haemoglobin, Mon 12, n=167 -0.7  (9.61)
Haemoglobin, Mon 16, n=98 -2.5  (9.96)
Haemoglobin, Mon 20, n=96 -1.4  (9.34)
Haemoglobin, Mon 24, n=110 -2.2  (8.76)
Haemoglobin, Mon 28, n=85 -3.2  (9.49)
Haemoglobin, Mon 32, n=86 -2.2  (8.84)
Haemoglobin, Mon 36, n=91 -3.3  (10.04)
Haemoglobin, Mon 40, n=78 -3.4  (10.88)
Haemoglobin, Mon 44, n=74 -2.3  (9.74)
Haemoglobin, Mon 48, n=79 -4.3  (11.13)
Haemoglobin, Mon 52, n=68 -2.0  (9.51)
Haemoglobin, Mon 56, n=63 -2.8  (9.33)
Haemoglobin, Mon 60, n=71 -2.9  (10.15)
Haemoglobin, Mon 64, n=49 -3.7  (10.55)
Haemoglobin, Mon 68, n=44 -2.0  (10.41)
Haemoglobin, Mon 72, n=53 -3.8  (11.03)
Haemoglobin, Mon 76, n=31 -3.1  (11.65)
Haemoglobin, Mon 80, n=24 -3.7  (9.24)
Haemoglobin, Mon 84, n=35 -3.8  (11.97)
Haemoglobin, Mon 88, n=16 -3.1  (9.76)
Haemoglobin, Mon 92, n=15 0.7  (9.14)
Haemoglobin, Mon 96, n=19 -2.1  (7.57)
Haemoglobin, Mon 100, n=7 2.6  (8.87)
Haemoglobin, Mon 104, n=1 8.0 [1]   (NA)
Haemoglobin, Mon 108, n=10 0.5  (7.47)
[1]
Standard deviation value was not available as only one participant was analyzed
15.Primary Outcome
Title Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)
Hide Description Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: International units per litre (IU/L)
AP, Mon 1, n=151 -5.5  (19.98)
AP, Mon 3, n=136 -5.7  (19.47)
AP, Mon 6, n=122 -7.3  (19.09)
AP, Mon 9, n=108 -7.7  (23.88)
AP, Mon 12, n=149 -6.1  (21.91)
AP, Mon 16, n=87 -9.1  (22.30)
AP, Mon 20, n=85 -5.0  (23.46)
AP, Mon 24, n=95 -7.1  (22.88)
AP, Mon 28, n=75 -6.3  (23.89)
AP, Mon 32, n=73 -7.8  (23.52)
AP, Mon 36, n=77 -4.8  (20.58)
AP, Mon 40, n=67 -6.3  (23.26)
AP, Mon 44, n=63 -8.2  (21.05)
AP, Mon 48, n=70 -7.5  (23.66)
AP, Mon 52, n=59 -9.7  (22.18)
AP, Mon 56, n=54 -9.9  (23.41)
AP, Mon 60, n=61 -7.7  (21.83)
AP, Mon 64, n=44 -2.8  (29.20)
AP, Mon 68, n=36 -8.7  (24.79)
AP, Mon 72, n=46 -4.5  (24.32)
AP, Mon 76, n=26 -5.0  (23.34)
AP, Mon 80, n=21 -8.9  (28.32)
AP, Mon 84, n=30 -1.7  (24.36)
AP, Mon 88, n=15 -9.9  (19.57)
AP, Mon 92, n=15 -6.5  (24.01)
AP, Mon 96, n=18 -3.9  (17.32)
AP, Mon 100, n=6 -12.3  (26.47)
AP, Mon 104, n=1 11.0 [1]   (NA)
AP, Mon 108, n=9 -14.2  (21.81)
ALT, Mon 1, n=169 3.1  (16.74)
ALT, Mon 3, n=152 4.0  (16.61)
ALT, Mon 6, n=137 1.2  (10.45)
ALT, Mon 9, n=122 5.2  (43.44)
ALT, Mon 12, n=169 4.5  (26.42)
ALT, Mon 16, n=100 -0.3  (11.05)
ALT, Mon 20, n=96 1.1  (10.89)
ALT, Mon 24, n=108 3.0  (11.61)
ALT, Mon 28, n=87 2.2  (12.65)
ALT, Mon 32, n=85 2.0  (14.39)
ALT, Mon 36, n=89 1.7  (10.36)
ALT, Mon 40, n=77 2.5  (12.6)
ALT, Mon 44, n=73 4.1  (13.29)
ALT, Mon 48, n=78 3.0  (12.25)
ALT, Mon 52, n=67 2.3  (12.15)
ALT, Mon 56, n=62 1.4  (9.94)
ALT, Mon 60, n=69 1.0  (11.73)
ALT, Mon 64, n=48 0.2  (10.24)
ALT, Mon 68, n=41 -0.5  (9.11)
ALT, Mon 72, n=51 0.4  (10.15)
ALT, Mon 76, n=30 0.6  (6.14)
ALT, Mon 80, n=22 0.4  (12.38)
ALT, Mon 84, n=33 1.1  (12.05)
ALT, Mon 88, n=15 -1.3  (12.29)
ALT, Mon 92, n=15 2.1  (8.09)
ALT, Mon 96, n=18 2.2  (13.81)
ALT, Mon 100, n=6 0.8  (9.41)
ALT, Mon 104, n=1 -6.0 [1]   (NA)
ALT, Mon 108, n=9 -1.3  (6.86)
AST, Mon 1, n=169 2.9  (10.79)
AST, Mon 3, n=152 3.2  (10.07)
AST, Mon 6, n=137 1.7  (7.89)
AST, Mon 9, n=121 6.0  (35.18)
AST, Mon 12, n=169 3.9  (14.84)
AST, Mon 16, n=100 2.1  (8.49)
AST, Mon 20, n=96 2.9  (8.03)
AST, Mon 24, n=108 4.1  (9.72)
AST, Mon 28, n=86 4.3  (9.16)
AST, Mon 32, n=85 5.6  (8.64)
AST, Mon 36, n=89 3.9  (6.74)
AST, Mon 40, n=77 5.0  (9.93)
AST, Mon 44, n=73 4.6  (7.84)
AST, Mon 48, n=78 4.7  (8.61)
AST, Mon 52, n=67 6.0  (8.68)
AST, Mon 56, n=62 4.3  (7.61)
AST, Mon 60, n=69 5.4  (9.34)
AST, Mon 64, n=48 3.8  (8.50)
AST, Mon 68, n=41 5.3  (7.13)
AST, Mon 72, n=51 5.1  (9.54)
AST, Mon 76, n=30 4.9  (6.59)
AST, Mon 80, n=22 4.6  (7.74)
AST, Mon 84, n=33 5.6  (8.60)
AST, Mon 88, n=15 2.9  (6.99)
AST, Mon 92, n=15 3.3  (3.24)
AST, Mon 96, n=18 3.1  (6.58)
AST, Mon 100, n=6 3.7  (4.23)
AST, Mon 104, n=1 2.0 [1]   (NA)
AST, Mon 108, n=9 1.8  (5.49)
[1]
Standard deviation value was not available as only one participant was analyzed
16.Primary Outcome
Title Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea
Hide Description Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Millimole per liter (mmol/L)
BUN, Mon 3, n=142 0.843  (1.2012)
BUN, Mon 6, n=130 0.917  (1.3506)
BUN, Mon 9, n=115 0.823  (1.4786)
BUN, Mon 12, n=156 0.717  (1.3707)
BUN, Mon 16, n=94 0.973  (1.5385)
BUN, Mon 20, n=92 1.060  (1.3001)
BUN, Mon 24, n=102 0.809  (1.3654)
BUN, Mon 28, n=82 0.876  (1.6420)
BUN, Mon 32, n=80 0.942  (1.5201)
BUN, Mon 36, n=85 0.958  (1.4267)
BUN, Mon 40, n=72 1.135  (1.5626)
BUN, Mon 44, n=69 0.844  (1.5006)
BUN, Mon 48, n=75 0.952  (1.5679)
BUN, Mon 52, n=62 1.071  (1.4554)
BUN, Mon 56, n=57 1.022  (1.2697)
BUN, Mon 60, n=64 1.100  (1.4931)
BUN, Mon 64, n=44 0.991  (1.5938)
BUN, Mon 68, n=37 1.148  (1.4599)
BUN, Mon 72, n=48 1.087  (1.6218)
BUN, Mon 76, n=27 1.257  (1.4492)
BUN, Mon 80, n=19 0.939  (1.6115)
BUN, Mon 84, n=30 0.929  (1.6810)
BUN, Mon 88, n=15 0.881  (1.458)
BUN, Mon 92, n=15 1.332  (1.9374)
BUN, Mon 96, n=18 0.916  (1.8800)
BUN, Mon 100, n=6 1.248  (1.5755)
BUN, Mon 104, n=1 1.430 [1]   (NA)
BUN, Mon 108, n=9 0.183  (1.2637)
Ca, Mon 1, n=170 -0.034  (0.1094)
Ca, Mon 3, n=152 -0.013  (0.1107)
Ca, Mon 6, n=137 0.012  (0.1035)
Ca, Mon 9, n=123 0.020  (0.1006)
Ca, Mon 12, n=169 0.024  (0.1167)
Ca, Mon 16, n=100 0.042  (0.1143)
Ca, Mon 20, n=97 0.052  (0.1180)
Ca, Mon 24, n=109 0.049  (0.1095)
Ca, Mon 28, n=87 0.034  (0.1135)
Ca, Mon 32, n=85 0.032  (0.1216)
Ca, Mon 36, n=89 0.032  (0.1176)
Ca, Mon 40, n=77 0.030  (0.1195)
Ca, Mon 44, n=73 0.040  (0.1093)
Ca, Mon 48, n=80 0.054  (0.1161)
Ca, Mon 52, n=67 0.047  (0.1170)
Ca, Mon 56, n=62 0.055  (0.0951)
Ca, Mon 60, n=69 0.061  (0.1184)
Ca, Mon 64, n=49 0.056  (0.1338)
Ca, Mon 68, n=41 0.083  (0.1245)
Ca, Mon 72, n=51 0.053  (0.1223)
Ca, Mon 76, n=30 0.097  (0.1341)
Ca, Mon 80, n=22 0.069  (0.1289)
Ca, Mon 84, n=34 0.106  (0.1023)
Ca, Mon 88, n=15 0.071  (0.1078)
Ca, Mon 92, n=15 0.116  (0.1013)
Ca, Mon 96, n=18 0.106  (0.0887)
Ca, Mon 100, n=6 0.148  (0.1217)
Ca, Mon 104, n=1 0.170 [1]   (NA)
Ca, Mon 108, n=9 0.139  (0.1122)
Cho., Mon 3, n=151 0.075  (0.6672)
Cho., Mon 6, n=137 0.069  (0.6811)
Cho., Mon 9, n=122 0.177  (0.7230)
Cho., Mon 12, n=169 0.222  (0.7098)
Cho., Mon 16, n=100 0.310  (0.7312)
Cho., Mon 20, n=97 0.304  (0.7883)
Cho., Mon 24, n=109 0.260  (0.7731)
Cho., Mon 28, n=87 0.261  (0.7771)
Cho., Mon 32, n=85 0.261  (0.8061)
Cho., Mon 36, n=89 0.212  (0.8312)
Cho., Mon 40, n=77 0.200  (0.7782)
Cho., Mon 44, n=73 0.348  (0.7824)
Cho., Mon 48, n=79 0.170  (0.8571)
Cho., Mon 52, n=67 0.299  (0.7230)
Cho., Mon 56, n=62 0.305  (0.7202)
Cho., Mon 60, n=69 0.360  (0.7318)
Cho., Mon 64, n=49 0.256  (0.8771)
Cho., Mon 68, n=41 0.352  (0.8486)
Cho., Mon 72, n=51 0.216  (0.8548)
Cho., Mon 76, n=30 0.555  (0.7532)
Cho., Mon 80, n=22 0.442  (0.7078)
Cho., Mon 84, n=34 0.459  (0.9991)
Cho., Mon 88, n=15 0.408  (0.7559)
Cho., Mon 92, n=15 0.526  (0.7639)
Cho., Mon 96, n=18 0.352  (0.628)
Cho., Mon 100, n=6 0.483  (0.4126)
Cho., Mon 104, n=1 0.160 [1]   (NA)
Cho., Mon 108, n=9 0.278  (0.3881)
NFG, Mon 1, n=170 0.11  (0.929)
NFG, Mon 3, n=149 0.20  (0.844)
NFG, Mon 6, n=133 0.18  (1.057)
NFG, Mon 9, n=120 0.38  (2.585)
NFG, Mon 12, n=166 0.20  (0.978)
NFG, Mon 16, n=100 0.18  (1.167)
NFG, Mon 20, n=94 0.26  (0.971)
NFG, Mon 24, n=106 0.13  (0.935)
NFG, Mon 28, n=86 0.22  (0.968)
NFG, Mon 32, n=85 0.16  (1.39)
NFG, Mon 36, n=89 0.19  (1.176)
NFG, Mon 40, n=75 0.20  (1.074)
NFG, Mon 44, n=72 0.02  (1.019)
NFG, Mon 48, n=77 0.27  (1.628)
NFG, Mon 52, n=67 0.05  (0.877)
NFG, Mon 56, n=61 0.14  (0.893)
NFG, Mon 60, n=69 0.19  (1.029)
NFG, Mon 64, n=49 0.21  (0.883)
NFG, Mon 68, n=39 0.32  (0.700)
NFG, Mon 72, n=51 0.24  (1.037)
NFG, Mon 76, n=30 0.17  (0.505)
NFG, Mon 80, n=22 0.15  (0.776)
NFG, Mon 84, n=34 0.23  (0.572)
NFG, Mon 88, n=15 -0.09  (0.593)
NFG, Mon 92, n=15 0.14  (0.546)
NFG, Mon 96, n=18 0.22  (0.493)
NFG, Mon 100, n=6 0.25  (0.176)
NFG, Mon 104, n=1 -0.50 [1]   (NA)
NFG, Mon 108, n=9 0.21  (0.372)
P, Mon 1, n=169 0.014  (0.2037)
P, Mon 3, n=148 0.001  (0.2029)
P, Mon 6, n=132 0.020  (0.2148)
P, Mon 9, n=119 0.021  (0.1974)
P, Mon 12, n=167 0.007  (0.2401)
P, Mon 16, n=100 -0.010  (0.2289)
P, Mon 20, n=94 0.003  (0.2229)
P, Mon 24, n=105 -0.021  (0.2186)
P, Mon 28, n=86 -0.020  (0.1974)
P, Mon 32, n=84 0.019  (0.1767)
P, Mon 36, n=88 0.004  (0.2896)
P, Mon 40, n=75 -0.005  (0.2408)
P, Mon 44, n=73 0.018  (0.2631)
P, Mon 48, n=78 0.019  (0.2165)
P, Mon 52, n=67 0.018  (0.2160)
P, Mon 56, n=62 0.010  (0.2330)
P, Mon 60, n=69 0.071  (0.2389)
P, Mon 64, n=49 0.027  (0.2722)
P, Mon 68, n=39 0.007  (0.2453)
P, Mon 72, n=51 0.029  (0.2761)
P, Mon 76, n=30 0.038  (0.2506)
P, Mon 80, n=22 0.107  (0.2761)
P, Mon 84, n=34 0.046  (0.2518)
P, Mon 88, n=15 -0.004  (0.2970)
P, Mon 92, n=15 0.058  (0.3334)
P, Mon 96, n=18 0.026  (0.3294)
P, Mon 100, n=6 0.143  (0.1656)
P, Mon 104, n=1 -0.090 [1]   (NA)
P, Mon 108, n=9 -0.068  (0.3755)
Ka, Mon 1, n=169 0.02  (0.416)
Ka, Mon 3, n=149 0.04  (0.433)
Ka, Mon 6, n=132 0.03  (0.362)
Ka, Mon 9, n=119 0.08  (0.432)
Ka, Mon 12, n=167 -0.03  (0.442)
Ka, Mon 16, n=100 0.02  (0.428)
Ka, Mon 20, n=93 0.10  (0.442)
Ka, Mon 24, n=106 -0.00  (0.435)
Ka, Mon 28, n=86 -0.01  (0.437)
Ka, Mon 32, n=84 0.01  (0.408)
Ka, Mon 36, n=88 0.04  (0.482)
Ka, Mon 40, n=74 0.00  (0.432)
Ka, Mon 44, n=74 0.16  (0.538)
Ka, Mon 48, n=79 0.12  (0.400)
Ka, Mon 52, n=67 0.20  (0.448)
Ka, Mon 56, n=62 0.08  (0.374)
Ka, Mon 60, n=69 0.13  (0.511)
Ka, Mon 64, n=49 0.19  (0.407)
Ka, Mon 68, n=40 0.28  (0.394)
Ka, Mon 72, n=52 0.24  (0.546)
Ka, Mon 76, n=30 0.25  (0.549)
Ka, Mon 80, n=22 0.35  (0.448)
Ka, Mon 84, n=34 0.24  (0.483)
Ka, Mon 88, n=15 0.38  (0.430)
Ka, Mon 92, n=15 0.55  (0.503)
Ka, Mon 96, n=18 0.41  (0.407)
Ka, Mon 100, n=6 0.32  (0.402)
Ka, Mon 104, n=1 1.10 [1]   (NA)
Ka, Mon 108, n=9 0.51  (0.437)
Na, Mon 1, n=170 1.5  (3.44)
Na, Mon 3, n=153 1.4  (2.88)
Na, Mon 6, n=137 1.8  (3.16)
Na, Mon 9, n=123 1.5  (3.22)
Na, Mon 12, n=170 1.1  (3.68)
Na, Mon 16, n=100 1.3  (3.26)
Na, Mon 20, n=97 1.1  (3.33)
Na, Mon 24, n=110 0.8  (3.57)
Na, Mon 28, n=87 1.4  (3.06)
Na, Mon 32, n=85 1.2  (3.46)
Na, Mon 36, n=89 1.3  (3.84)
Na, Mon 40, n=77 1.6  (3.78)
Na, Mon 44, n=74 1.4  (3.78)
Na, Mon 48, n=80 1.2  (3.31)
Na, Mon 52, n=67 1.5  (4.09)
Na, Mon 56, n=62 2.2  (3.21)
Na, Mon 60, n=69 1.6  (3.46)
Na, Mon 64, n=49 2.3  (3.63)
Na, Mon 68, n=42 2.8  (3.64)
Na, Mon 72, n=52 2.5  (3.60)
Na, Mon 76, n=30 3.7  (3.43)
Na, Mon 80, n=22 3.5  (4.15)
Na, Mon 84, n=34 2.9  (4.04)
Na, Mon 88, n=15 3.4  (3.18)
Na, Mon 92, n=15 2.8  (2.46)
Na, Mon 96, n=18 2.9  (2.24)
Na, Mon 100, n=6 3.5  (4.09)
Na, Mon 104, n=1 8.0 [1]   (NA)
Na, Mon 108, n=9 3.8  (4.35)
Urea, Mon 1, n=13 0.712  (1.1012)
Urea, Mon 3, n=10 0.533  (0.5127)
Urea, Mon 6, n=7 0.304  (1.1204)
Urea, Mon 9, n=8 0.846  (1.1121)
Urea, Mon 12, n=13 0.713  (0.8743)
Urea, Mon 16, n=6 1.070  (2.1793)
Urea, Mon 20, n=5 0.856  (0.7814)
Urea, Mon 24, n=8 0.668  (1.0143)
Urea, Mon 28, n=5 1.498  (0.9608)
Urea, Mon 32, n=5 0.784  (0.7722)
Urea, Mon 36, n=4 1.337  (1.5564)
Urea, Mon 40, n=5 1.140  (0.4659)
Urea, Mon 44, n=5 0.784  (0.5269)
Urea, Mon 48, n=5 0.712  (1.1305)
Urea, Mon 52, n=5 0.356  (0.9411)
Urea, Mon 56, n=5 1.356  (1.7009)
Urea, Mon 60, n=5 1.282  (1.7228)
Urea, Mon 64, n=5 1.496  (0.8128)
Urea, Mon 68, n=4 1.695  (1.0242)
Urea, Mon 72, n=3 1.070  (2.1725)
Urea, Mon 76, n=3 1.070  (0.9430)
Urea, Mon 80, n=3 2.380  (0.7398)
Urea, Mon 84, n=4 1.695  (1.9006)
Bicarbonate, Mon 1, n=169 0.4  (3.13)
Bicarbonate, Mon 3, n=151 0.0  (3.27)
Bicarbonate, Mon 6, n=136 0.4  (3.65)
Bicarbonate, Mon 9, n=122 0.7  (3.48)
Bicarbonate, Mon 12, n=169 -0.0  (3.97)
Bicarbonate, Mon 16, n=100 1.2  (3.49)
Bicarbonate, Mon 20, n=97 1.5  (4.02)
Bicarbonate, Mon 24, n=109 1.1  (3.28)
Bicarbonate, Mon 28, n=87 1.6  (3.67)
Bicarbonate, Mon 32, n=85 1.7  (3.62)
Bicarbonate, Mon 36, n=89 1.6  (3.84)
Bicarbonate, Mon 40, n=76 1.9  (3.89)
Bicarbonate, Mon 44, n=73 2.7  (3.99)
Bicarbonate, Mon 48, n=79 2.4  (3.43)
Bicarbonate, Mon 52, n=66 2.8  (3.65)
Bicarbonate, Mon 56, n=62 1.8  (3.79)
Bicarbonate, Mon 60, n=69 2.4  (4.33)
Bicarbonate, Mon 64, n=49 1.9  (3.95)
Bicarbonate, Mon 68, n=42 2.0  (3.84)
Bicarbonate, Mon 72, n=51 1.8  (3.59)
Bicarbonate, Mon 76, n=30 2.2  (4.04)
Bicarbonate, Mon 80, n=22 2.2  (3.74)
Bicarbonate, Mon 84, n=34 3.0  (5.49)
Bicarbonate, Mon 88, n=15 1.7  (2.09)
Bicarbonate, Mon 92, n=15 1.7  (2.55)
Bicarbonate, Mon 96, n=18 1.2  (3.73)
Bicarbonate, Mon 100, n=6 -0.7  (1.86)
Bicarbonate, Mon 104, n=1 1.0 [1]   (NA)
Bicarbonate, Mon 108, n=9 -0.4  (2.30)
Cl, Mon 1, n=170 1.3  (3.38)
Cl, Mon 3, n=153 1.3  (3.06)
Cl, Mon 6, n=137 1.4  (3.32)
Cl, Mon 9, n=123 1.6  (3.59)
Cl, Mon 12, n=169 1.0  (3.73)
Cl, Mon 16, n=100 1.8  (3.24)
Cl, Mon 20, n=97 1.2  (3.56)
Cl, Mon 24, n=110 1.0  (4.12)
Cl, Mon 28, n=87 1.6  (3.45)
Cl, Mon 32, n=85 1.8  (3.70)
Cl, Mon 36, n=89 1.5  (4.00)
Cl, Mon 40, n=77 1.6  (4.12)
Cl, Mon 44, n=74 1.3  (3.81)
Cl, Mon 48, n=80 1.2  (3.61)
Cl, Mon 52, n=67 1.4  (4.13)
Cl, Mon 56, n=61 2.0  (3.29)
Cl, Mon 60, n=69 1.0  (3.77)
Cl, Mon 64, n=49 1.7  (3.44)
Cl, Mon 68, n=42 1.2  (3.62)
Cl, Mon 72, n=52 1.6  (3.70)
Cl, Mon 76, n=30 1.6  (4.11)
Cl, Mon 80, n=22 2.0  (3.54)
Cl, Mon 84, n=34 0.9  (3.53)
Cl, Mon 88, n=15 2.2  (2.31)
Cl, Mon 92, n=15 0.9  (3.11)
Cl, Mon 96, n=18 0.7  (3.66)
Cl, Mon 100, n=6 1.8  (4.26)
Cl, Mon 104, n=1 1.0 [1]   (NA)
Cl, Mon 108, n=9 0.8  (3.56)
[1]
Standard deviation value was not available as only one participant was analyzed
17.Primary Outcome
Title Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)
Hide Description Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Micromole per Liter (umol/L)
Creatinine, Mon 1, n=170 3  (12.20)
Creatinine, Mon 3, n=149 4  (13.74)
Creatinine, Mon 6, n=133 4.9  (13.47)
Creatinine, Mon 9, n=120 3.7  (14.88)
Creatinine, Mon 12, n=167 4.5  (13.91)
Creatinine, Mon 16, n=100 4.0  (15.25)
Creatinine, Mon 20, n=94 3.0  (15.67)
Creatinine, Mon 24, n=105 1.9  (17.15)
Creatinine, Mon 28, n=86 -1.0  (13.98)
Creatinine, Mon 32, n=84 0.0  (16.60)
Creatinine, Mon 36, n=88 -0.9  (14.90)
Creatinine, Mon 40, n=75 0.1  (14.38)
Creatinine, Mon 44, n=73 -1.0  (13.93)
Creatinine, Mon 48, n=79 -0.2  (15.16)
Creatinine, Mon 52, n=67 0.1  (14.84)
Creatinine, Mon 56, n=62 1.2  (11.42)
Creatinine, Mon 60, n=69 -0.2  (15.54)
Creatinine, Mon 64, n=49 0.6  (15.19)
Creatinine, Mon 68, n=39 0.7  (14.31)
Creatinine, Mon 72, n=51 0.1  (14.35)
Creatinine, Mon 76, n=30 0.5  (14.75)
Creatinine, Mon 80, n=22 3.3  (13.38)
Creatinine, Mon 84, n=34 1.6  (18.72)
Creatinine, Mon 88, n=15 1.2  (12.37)
Creatinine, Mon 92, n=15 4.3  (12.45)
Creatinine, Mon 96, n=18 1.2  (10.86)
Creatinine, Mon 100, n=6 6.2  (12.06)
Creatinine, Mon 104, n=1 9.0 [1]   (NA)
Creatinine, Mon 108, n=9 5.3  (14.40)
TB Mon 1, n=167 4.6  (4.06)
TB Mon 3, n=150 4.5  (4.34)
TB Mon 6, n=134 3.8  (4.04)
TB Mon 9, n=120 3.6  (4.40)
TB Mon 12, n=167 2.7  (4.10)
TB Mon 16, n=100 3.6  (4.41)
TB Mon 20, n=97 3.7  (3.89)
TB Mon 24, n=109 2.6  (4.10)
TB Mon 28, n=87 2.8  (4.26)
TB Mon 32, n=85 2.4  (4.95)
TB Mon 36, n=89 2.2  (4.26)
TB Mon 40, n=77 2.7  (4.68)
TB Mon 44, n=73 2.6  (4.33)
TB Mon 48, n=78 2.2  (4.98)
TB Mon 52, n=67 2.0  (4.75)
TB Mon 56, n=62 2.1  (4.54)
TB Mon 60, n=68 2.1  (4.75)
TB Mon 64, n=48 1.6  (4.56)
TB Mon 68, n=41 1.2  (4.97)
TB Mon 72, n=51 0.8  (4.64)
TB Mon 76, n=29 1.0  (4.38)
TB Mon 80, n=22 1.3  (3.69)
TB Mon 84, n=34 -0.3  (4.09)
TB Mon 88, n=15 2.1  (7.05)
TB Mon 92, n=15 1.3  (4.89)
TB Mon 96, n=18 -0.2  (5.06)
TB Mon 100, n=6 1.2  (4.49)
TB Mon 104, n=1 9.0 [1]   (NA)
TB Mon 108, n=9 -0.3  (2.24)
UA Mon 1, n=170 0.8  (39.49)
UA Mon 3, n=152 3.1  (47.06)
UA Mon 6, n=137 2.9  (44.98)
UA Mon 9, n=123 4.5  (48.74)
UA Mon 12, n=169 6.6  (50.88)
UA Mon 16, n=100 2.5  (55.01)
UA Mon 20, n=97 2.3  (49.72)
UA Mon 24, n=109 4.7  (53.68)
UA Mon 28, n=87 12.2  (51.73)
UA Mon 32, n=85 10.2  (48.23)
UA Mon 36, n=89 5.3  (52.19)
UA Mon 40, n=77 6.9  (45.40)
UA Mon 44, n=73 4.3  (53.75)
UA Mon 48, n=79 5.7  (45.68)
UA Mon 52, n=67 4.2  (52.86)
UA Mon 56, n=62 8.6  (42.81)
UA Mon 60, n=69 8.1  (49.74)
UA Mon 64, n=49 2.7  (52.52)
UA Mon 68, n=41 5.4  (52.49)
UA Mon 72, n=51 12.6  (56.31)
UA Mon 76, n=30 11.9  (53.61)
UA Mon 80, n=22 7.0  (50.68)
UA Mon 84, n=34 5.7  (58.19)
UA Mon 88, n=15 3.1  (57.81)
UA Mon 92, n=15 -6.0  (60.45)
UA Mon 96, n=18 5.3  (52.95)
UA Mon 100, n=6 35.7  (62.78)
UA Mon 104, n=1 107.0 [1]   (NA)
UA Mon 108, n=9 17.9  (59.95)
[1]
Standard deviation value was not available as only one participant was analyzed
18.Primary Outcome
Title Change From Baseline in Chemistry Parameter-Total Protein
Hide Description Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Baseline and Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Grams per liter (g/L)
TP Mon 1, n=170 -1.1  (4.44)
TP Mon 3, n=152 -0.5  (4.87)
TP Mon 6, n=137 -1.0  (4.77)
TP Mon 9, n=123 -0.8  (4.60)
TP Mon 12, n=169 0.2  (4.45)
TP Mon 16, n=100 0.3  (5.15)
TP Mon 20, n=97 0.8  (4.64)
TP Mon 24, n=109 0.2  (4.67)
TP Mon 28, n=87 -0.2  (4.52)
TP Mon 32, n=85 0.1  (4.55)
TP Mon 36, n=89 -1.1  (4.48)
TP Mon 40, n=77 -1.1  (4.46)
TP Mon 44, n=73 -0.1  (4.72)
TP Mon 48, n=79 -1.3  (4.34)
TP Mon 52, n=67 -0.7  (4.67)
TP Mon 56, n=62 -1.1  (4.32)
TP Mon 60, n=69 -0.7  (4.75)
TP Mon 64, n=49 -0.2  (4.86)
TP Mon 68, n=41 0.6  (4.82)
TP Mon 72, n=51 -0.7  (5.17)
TP Mon 76, n=30 0.8  (4.93)
TP Mon 80, n=22 0.3  (4.82)
TP Mon 84, n=34 0.7  (5.90)
TP Mon 88, n=15 0.4  (5.29)
TP Mon 92, n=15 1.0  (4.09)
TP Mon 96, n=18 0.9  (3.20)
TP Mon 100, n=6 2.0  (4.77)
TP Mon 104, n=1 7.0 [1]   (NA)
TP Mon 108, n=9 2.1  (4.94)
[1]
Standard deviation value was not available as only one participant was analyzed.
19.Primary Outcome
Title Change From Baseline in Urine Specific Gravity
Hide Description Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Dimensionless unit
USG, Mon 1, n=166 -0.0018  (0.00848)
USG, Mon 3, n=157 -0.0016  (0.00852)
USG, Mon 6, n=137 0.0002  (0.00930)
USG, Mon 9, n=121 0.0002  (0.00933)
USG, Mon 12, n=170 -0.0000  (0.00937)
USG, Mon 16, n=100 0.0006  (0.00960)
USG, Mon 20, n=97 0.0008  (0.00964)
USG, Mon 24, n=109 -0.0012  (0.00985)
USG, Mon 28, n=86 -0.0003  (0.01032)
USG, Mon 32, n=82 -0.0006  (0.00935)
USG, Mon 36, n=89 -0.0024  (0.0086)
USG, Mon 40, n=76 -0.0005  (0.00865)
USG, Mon 44, n=72 -0.0007  (0.00867)
USG, Mon 48, n=80 -0.0015  (0.00941)
USG, Mon 52, n=67 0.0002  (0.00972)
USG, Mon 56, n=62 -0.0003  (0.00899)
USG, Mon 60, n=68 -0.0023  (0.00893)
USG, Mon 64, n=49 -0.0022  (0.00938)
USG, Mon 68, n=42 -0.0022  (0.00822)
USG, Mon 72, n=53 -0.0015  (0.01006)
USG, Mon 76, n=31 -0.0024  (0.00822)
USG, Mon 80, n=23 -0.0021  (0.00867)
USG, Mon 84, n=35 -0.0028  (0.00862)
USG, Mon 88, n=17 -0.0055  (0.00833)
USG, Mon 92, n=16 -0.0030  (0.01116)
USG, Mon 96, n=19 -0.0039  (0.00956)
USG, Mon 100, n=7 -0.0013  (0.00886)
USG, Mon 104, n=1 -0.0150 [1]   (NA)
USG, Mon 108, n=10 -0.0014  (0.01032)
[1]
Standard deviation value was not available as only one participant was analyzed
20.Primary Outcome
Title Change From Baseline in Urine Power of Hydrogen (pH)
Hide Description Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame Baseline and Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: pH units
UpH, Mon 1, n=166 -0.13  (0.721)
UpH, Mon 3, n=157 -0.18  (0.791)
UpH, Mon 6, n=137 -0.13  (0.767)
UpH, Mon 9, n=121 -0.17  (0.771)
UpH, Mon 12, n=170 -0.11  (0.793)
UpH, Mon 16, n=100 -0.05  (0.764)
UpH, Mon 20, n=97 -0.20  (0.886)
UpH, Mon 24, n=109 -0.09  (0.713)
UpH, Mon 28, n=86 -0.01  (0.893)
UpH, Mon 32, n=82 -0.10  (0.768)
UpH, Mon 36, n=89 0.12  (0.83)
UpH, Mon 40, n=76 0.09  (0.842)
UpH, Mon 44, n=72 0.12  (0.767)
UpH, Mon 48, n=80 0.19  (0.828)
UpH, Mon 52, n=67 0.17  (0.851)
UpH, Mon 56, n=62 0.06  (0.769)
UpH, Mon 60, n=68 0.24  (0.896)
UpH, Mon 64, n=49 0.19  (0.934)
UpH, Mon 68, n=42 0.12  (0.825)
UpH, Mon 72, n=53 0.16  (0.842)
UpH, Mon 76, n=31 0.13  (1.000)
UpH, Mon 80, n=23 0.24  (0.890)
UpH, Mon 84, n=36 0.00  (0.862)
UpH, Mon 88, n=17 0.21  (1.032)
UpH, Mon 92, n=16 0.28  (1.224)
UpH, Mon 96, n=19 0.26  (0.888)
UpH, Mon 100, n=7 0.14  (1.180)
UpH, Mon 104, n=1 0.50 [1]   (NA)
UpH, Mon 108, n=10 0.65  (0.747)
[1]
Standard deviation value was not available as only one participant was analyzed
21.Primary Outcome
Title Change From Baseline in Post-void Residual Bladder Ultrasound Volume
Hide Description Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Baseline and Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Milliliter (mL)
PVR, Mon 1, n=152 6.5  (60.92)
PVR, Mon 3, n=146 5.8  (59.69)
PVR, Mon 12, n=144 -2.8  (73.95)
PVR, Mon 24, n=75 11.6  (62.06)
PVR, Mon 36, n=84 13.6  (58.45)
PVR, Mon 48, n=77 8.8  (62.28)
PVR, Mon 60, n=65 20.1  (85.81)
PVR, Mon 72, n=48 17.2  (61.82)
PVR, Mon 84, n=31 40.0  (89.38)
PVR, Mon 96, n=19 8.7  (23.32)
PVR, Mon 108, n=10 17.4  (60.89)
22.Primary Outcome
Title Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score
Hide Description An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant’s urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Baseline and Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
AUA, Mon 1, n=162 -0.2  (6.17)
AUA, Mon 3, n=151 -0.0  (5.66)
AUA, Mon 12, n=153 0.2  (6.30)
AUA, Mon 24, n=79 -0.1  (5.91)
AUA, Mon 36, n=81 0.0  (4.62)
AUA, Mon 48, n=79 0.5  (5.53)
AUA, Mon 60, n=65 0.6  (4.42)
AUA, Mon 72, n=49 0.4  (4.84)
AUA, Mon 84, n=33 1.0  (4.89)
AUA, Mon 96, n=19 -1.0  (3.76)
AUA, Mon 108, n=10 -0.3  (5.06)
23.Primary Outcome
Title Number of Participants With Abnormal Results in Physical Examination
Hide Description A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category
Time Frame Up to Month 108
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Safety Population
Arm/Group Title Overall Study Arm
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants
Baseline, n=181 59
Mon 12, n=169 49
Mon 24, n=113 34
Mon 36, n=92 27
Mon 48, n=82 25
Mon 60, 69 32
Mon 72, n=56 31
Mon 84, n=36 25
Mon 96, n=19 10
Mon 108, n=10 5
24.Primary Outcome
Title Number of Participants With Abnormal Results of Neurological Examination
Hide Description Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame Up to Month 108
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants
Baseline, n= 173, AbNCS 60
Baseline, n= 173, AbCS 11
Mon 1, n= 173, AbNCS 49
Mon 1, n= 173, AbCS 17
Mon 3, n= 159, AbNCS 42
Mon 3, n= 159, AbCS 9
Mon 6, n= 141, AbNCS 35
Mon 6, n= 141, AbCS 8
Mon 9, n= 125, AbNCS 32
Mon 9, n= 125, AbCS 9
Mon 12, n= 171, AbNCS 56
Mon 12, n= 171, AbCS 13
Mon 16, n= 104, AbNCS 23
Mon 16, n= 104, AbCS 10
Mon 20, n= 98, AbNCS 28
Mon 20, n= 98, AbCS 6
Mon 24, n= 113, AbNCS 35
Mon 24, n= 113, AbCS 6
Mon 28, n= 87, AbNCS 23
Mon 28, n= 87, AbCS 6
Mon 32, n= 86, AbNCS 19
Mon 32, n= 86, AbCS 5
Mon 36, n= 92, AbNCS 28
Mon 36, n= 92, AbCS 6
Mon 40, n= 78, AbNCS 22
Mon 40, n= 78, AbCS 8
Mon 44, n= 76, AbNCS 25
Mon 44, n= 76, AbCS 3
Mon 48, n= 82, AbNCS 25
Mon 48, n= 82, AbCS 6
Mon 52, n= 67, AbNCS 19
Mon 52, n= 67, AbCS 4
Mon 56, n= 63, AbNCS 19
Mon 56, n= 63, AbCS 4
Mon 60, n= 68, AbNCS 27
Mon 60, n= 68, AbCS 3
Mon 64, n= 50, AbNCS 21
Mon 64, n= 50, AbCS 1
Mon 68, n= 44, AbNCS 15
Mon 68, n= 44, AbCS 0
Mon 72, n= 56, AbNCS 20
Mon 72, n= 56, AbCS 4
Mon 76, n= 31, AbNCS 11
Mon 76, n= 31, AbCS 0
Mon 80, n= 24, AbNCS 7
Mon 80, n= 24, AbCS 0
Mon 84, n= 36, AbNCS 14
Mon 84, n= 36, AbCS 0
Mon 88, n= 17, AbNCS 0
Mon 88, n= 17, AbCS 1
Mon 92, n= 16, AbNCS 2
Mon 92, n= 16, AbCS 1
Mon 96, n= 19, AbNCS 4
Mon 96, n= 19, AbCS 0
Mon 100, n= 7, AbNCS 2
Mon 100, n= 7, AbCS 0
Mon 104, n= 1, AbNCS 1
Mon 104, n= 1, AbCS 0
Mon 108, n= 10, AbNCS 2
Mon 108, n= 10, AbCS 0
25.Primary Outcome
Title Number of Participants With Pigmentation of Non-retinal Ocular Tissue
Hide Description The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: Participants
11
26.Primary Outcome
Title Number of Participants With Pigmentation of Retinal Ocular Tissue
Hide Description The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: Participants
14
27.Primary Outcome
Title Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa
Hide Description An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants
Any abnormal dermatologic discoloration 23
Abnormal discoloration of skin 15
Abnormal discoloration of lips 16
Abnormal discoloration of nails 21
Abnormal discoloration of mucosa 17
Abnormal discoloration of sun-exposed tissue 22
Abnormal discoloration of non su-exposed tissue 18
28.Primary Outcome
Title Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
Hide Description A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
2
29.Primary Outcome
Title Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination
Hide Description Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: Participants
0
30.Primary Outcome
Title Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Hide Description The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.
Time Frame 2 years and 9 months
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Hide Analysis Population Description
All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.
Arm/Group Title Retigabine SFUCP
Hide Arm/Group Description:
Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
Retinal pigmentary abnormality 1
Pigmentary abnormality of macula 1
Pigmentary abnormality of peripheral retina 3
Non-retinal ocular pigmentary abnormality 4
31.Primary Outcome
Title Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine
Hide Description An assessment of the participant’s nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.
Time Frame 2 years 9 months
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Hide Analysis Population Description
All SFUCP Subjects Population
Arm/Group Title Retigabine SFUCP
Hide Arm/Group Description:
Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Participants
1
32.Primary Outcome
Title Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Hide Description Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.
Time Frame 2 years 9 months
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All SFUCP Subjects Population
Arm/Group Title Retigabine SFUCP
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Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: Days
Retinal Pigmentary Abnormality, n=1 Number Analyzed 1 participants
317.0
(317 to 317)
Pigmentary Abnormality of Macula, n=1 Number Analyzed 1 participants
163.0
(163 to 163)
Pigmentary Abnormality of Peripheral Retina, n=3 Number Analyzed 3 participants
317.0
(197 to 794)
Non-Retinal Ocular Pigmentary Abnormality, n=4 Number Analyzed 4 participants
180.0
(34 to 561)
33.Primary Outcome
Title Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Hide Description Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant’s skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.
Time Frame 2 years 9 months
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All SFUCP Subjects Population
Arm/Group Title Retigabine SFUCP
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Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: Days
All, n=1 Number Analyzed 1 participants
439.0
(439 to 439)
Skin, n=5 Number Analyzed 5 participants
347.0
(203 to 952)
Lips, n=4 Number Analyzed 4 participants
284.5
(133 to 590)
Nails,n=7 Number Analyzed 7 participants
377.0
(203 to 762)
Mucosa, n=3 Number Analyzed 3 participants
468.0
(133 to 541)
34.Secondary Outcome
Title Percentage Change From Baseline in the 28-day Partial Seizure
Hide Description Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 179
Mean (Standard Deviation)
Unit of Measure: Percent change
-34.2  (68.70)
35.Secondary Outcome
Title Number of Responders
Hide Description A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 179
Measure Type: Number
Unit of Measure: Participants
98
36.Secondary Outcome
Title Number of Participants Who Were Seizure Free for Any 6 Continuous Months
Hide Description Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Safety Population
Arm/Group Title Overall Study
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Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 140
Measure Type: Number
Unit of Measure: Participants
20
37.Secondary Outcome
Title Number of Participants Who Were Seizure Free for Any 12 Continuous Months
Hide Description Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time Frame Assessed up to a maximum of 9 years
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Hide Analysis Population Description
Safety Population
Arm/Group Title Overall Study
Hide Arm/Group Description:
Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Participants
14
38.Secondary Outcome
Title Percentage of Seizure-free Days
Hide Description Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days
Time Frame Assessed up to a maximum of 9 years
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