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Trial record 51 of 215 for:    Lamotrigine

Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy

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ClinicalTrials.gov Identifier: NCT00355082
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : November 25, 2009
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Epilepsy, Partial
Interventions Drug: lamotrigine, 300 mg/day
Drug: lamotrigine, 250 mg/day
Enrollment 226
Recruitment Details All participants in the Treatment phase and all Baseline Failure participants are eligible to enter the Continuation phase. The Continuation phase is for long-term safety exposure to lamotrigine extended release (LTG XR) at 300 mg/day; it is not a cross-over phase.
Pre-assignment Details The number of participants (par.) starting the Continuation phase (CP) does not equal the number completing the Treatment phase (TP), as 1) the CP was optional, 2) not everyone from the TP was eligible to enter the CP, and 3) par. who failed to qualify for the TP (Baseline Failures) were allowed to enter the CP. All par. start the TP at 300 mg/day.
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 250 mg Baseline Failures
Hide Arm/Group Description LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day. LTG XR, 250 mg/day Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
Period Title: Double-Blind (DB) Treatment Phase
Started 113 [1] 113 [2] 0
Completed 94 79 0
Not Completed 19 34 0
Reason Not Completed
Adverse Event             4             10             0
Withdrawal by Subject             9             8             0
Lack of Efficacy             6             7             0
Lost to Follow-up             0             4             0
Protocol Violation             0             4             0
Pregnancy             0             1             0
[1]
112 participants have baseline data; 1 participant did not receive study drug.
[2]
111 participants have baseline data; 2 participants did not receive study drug.
Period Title: Continuation Phase
Started 184 [1] 0 11 [2]
Completed 160 0 8
Not Completed 24 0 3
Reason Not Completed
Adverse Event             2             0             1
Lost to Follow-up             2             0             1
Protocol Violation             1             0             1
Withdrawal by Subject             4             0             0
Lack of Efficacy             5             0             0
Site Closed by Sponsor             8             0             0
Scheduling Error             1             0             0
Ran Out of Drug Due to Travel             1             0             0
[1]
83 and 101 participants from the 250 and 300 mg groups (DB Phase), respectively, entered the CP.
[2]
See "Pre-assign. Details" for reasons why number starting CP does not equal number completing TP.
Arm/Group Title Treatment Phase: LTG XR, 300 mg Treatment Phase: LTG XR, 250 mg Total
Hide Arm/Group Description LTG XR, 300 mg/day in the Treatment phase LTG XR, 250 mg/day in the Treatment phase Total of all reporting groups
Overall Number of Baseline Participants 112 111 223
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 111 participants 223 participants
33.8  (14.3) 32.9  (12.6) 33.4  (13.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 223 participants
Female
56
  50.0%
66
  59.5%
122
  54.7%
Male
56
  50.0%
45
  40.5%
101
  45.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 223 participants
African American 5 4 9
Asian 11 11 22
Arabic/North African 0 2 2
White 96 94 190
Asian - Central/South Asian 0 0 0
Asian - East Asian 0 0 0
Number of participants taking indicated concurrent antiepileptic drug at study entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 223 participants
Valproate 73 70 143
Levetiracetam 11 13 24
Oxcarbazepine 12 12 24
Topiramate 12 10 22
Zonisamide 3 5 8
Pregabalin 1 1 2
[1]
Measure Description: Antiepileptic drug (AED) being taken by participant at study entry; this characteristic is not applicable for the Continuation phase
1.Primary Outcome
Title The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
Hide Description The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who reached Visit 5 minus major protocol violators. The Control group is composed of data from other similar studies and is not part of this study.
Time Frame From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in the 300 mg/day dose group who began withdrawal of background antiepileptic drug (AED) (Visit 5) minus any major protocol violators
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg
Hide Arm/Group Description:
LTG XR, 300 mg/day
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: percentage of participants
12
2.Secondary Outcome
Title The Percentage of Participants in the 250 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase)
Hide Description The percentage of participants prematurely discontinuing the study was calculated as the number of participants who discontinued the study divided by the number who had reached Visit 5 minus major protocol violators. The Control group was composed of data from other similar studies and is not part of this study.
Time Frame From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in the 250 mg/day dose group who began withdrawal of background AED (Visit 5) minus any major protocol violators
Arm/Group Title LTG XR, 250 mg
Hide Arm/Group Description:
LTG XR, 250 mg/day
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: percentage of participants
16
3.Secondary Outcome
Title Time to Discontinuation in the Treatment Phase
Hide Description Time (days) until the participant discontinued the study
Time Frame From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants who were randomized and began dosing with study drug
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 250 mg
Hide Arm/Group Description:
LTG XR, 300 mg/day
LTG XR, 250 mg/day
Overall Number of Participants Analyzed 112 111
Mean (Standard Deviation)
Unit of Measure: Days
147.3  (31.5) 133.2  (45.6)
4.Secondary Outcome
Title Percentage of Participants Meeting Escape Criteria in the Treatment Phase
Hide Description The percentage of participants meeting Escape Criteria was calculated as the number of participants who met an Escape Criterion divided by the number who had reached Visit 5 minus major protocol violators. Escape Criteria are: (1) doubling of average monthly seizure frequency; (2) doubling of the highest consecutive 2-day seizure total; (3) occurrence of a new, more severe seizure type; or (4) worsening of generalized tonic-clonic seizures.
Time Frame Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 250 mg
Hide Arm/Group Description:
LTG XR, 300 mg/day
LTG XR, 250 mg/day
Overall Number of Participants Analyzed 93 81
Measure Type: Number
Unit of Measure: percentage of participants
4 6
5.Secondary Outcome
Title Percent Change From Baseline in Weekly Seizure Frequency Between Study Visits 3 (Start of Dosing) and 9 (End of the Treatment Phase)
Hide Description Change from Baseline was measured as the number of seizures at Visits 3 through 9 minus the number of seizures at Baseline. The number of partial seizures during treatment divided by the number of weeks of treatment was compared to the weekly seizure frequency during Baseline. A positive number equals a reduction in seizure frequency.
Time Frame Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 250 mg
Hide Arm/Group Description:
LTG XR, 300 mg/day
LTG XR, 250 mg/day
Overall Number of Participants Analyzed 93 81
Median (Full Range)
Unit of Measure: percent change in seizures
54.8
(-124.5 to 100.0)
52.2
(-221.3 to 100.0)
6.Secondary Outcome
Title Number of Seizure-free Participants During the Last 12 Weeks of Treatment of the Treatment Phase
Hide Description The number of participants who had no seizures during the treatment period was calculated. The last 12 weeks of treatment were either Weeks 11-22 or 12-23 depending on which background AED was being withdrawn
Time Frame The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who began withdrawal of background AED (Visit 5) minus any major protocol violators
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg LTG XR, 250 mg
Hide Arm/Group Description:
LTG XR, 300 mg/day
LTG XR, 250 mg/day
Overall Number of Participants Analyzed 89 76
Measure Type: Number
Unit of Measure: participants
22 8
7.Secondary Outcome
Title Percent Change From Baseline in the Average Seizure Frequency Measured at the End of Participation in the Continuation Phase
Hide Description Change from baseline was calculated as the average seizure frequency at the end of the Continuation Phase minus the average seizure frequency at Baseline. The number of seizures during the Continuation phase divided by the number of weeks was compared to the number of seizures at Baseline. A positive number indicates a reduction in seizure frequency.
Time Frame Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who began the Continuation Phase
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg Baseline Failures
Hide Arm/Group Description:
Treatment phase participants; LTG XR, 300 mg/day
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
Overall Number of Participants Analyzed 184 11
Median (Full Range)
Unit of Measure: percent change in seizures
72.2
(-840.7 to 100.0)
68.8
(-111 to 100)
8.Secondary Outcome
Title The Number of Participants With at Least the Specified Change in Seizure Frequency, Compared to Baseline, at the End of Participation in the Continuation Phase (Maximum of 24 Weeks)
Hide Description Change in seizure frequency was calculated as the average seizure frequency during the Continuation Phase minus the seizure frequency at Baseline.
Time Frame Baseline and entire Continuation phase (24 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who entered the Continuation Phase
Arm/Group Title Lamotrigine Extended-release (LTG XR), 300 mg Baseline Failures
Hide Arm/Group Description:
Treatment phase participants; LTG XR, 300 mg/day
Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
Overall Number of Participants Analyzed 184 11
Measure Type: Number
Unit of Measure: participants
At least a 25% reduction in seizures 169 7
At least a 50% reduction in seizures 137 6
At least a 75% reduction in seizures 85 3
100% reduction in seizures 38 2
At least a 50% increase in seizures 6 3
Time Frame [Not Specified]
Adverse Event Reporting Description For the Treatment phase, a frequency threshold of 5% in either treatment group was used. Because there are only 11 participants in the Baseline Failure group, only adverse events occurring in at least 3 participants in the 300 mg/day group are listed (1.6%).
 
Arm/Group Title Treatment Phase: LTG XR, 300 mg Treatment Phase: LTG XR, 250 mg Continuation Phase: LTG XR, 300 mg Continuation Phase: Baseline Failures
Hide Arm/Group Description LTG XR, 300 mg/day in the Treatment phase LTG XR, 250 mg/day in the Treatment phase Treatment phase participants; LTG XR, 300 mg/day Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
All-Cause Mortality
Treatment Phase: LTG XR, 300 mg Treatment Phase: LTG XR, 250 mg Continuation Phase: LTG XR, 300 mg Continuation Phase: Baseline Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Phase: LTG XR, 300 mg Treatment Phase: LTG XR, 250 mg Continuation Phase: LTG XR, 300 mg Continuation Phase: Baseline Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/112 (2.68%)   5/111 (4.50%)   3/184 (1.63%)   1/11 (9.09%) 
Gastrointestinal disorders         
Upper GI bleeding  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
General disorders         
Fever  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
Injury, poisoning and procedural complications         
Back injury  1  0/112 (0.00%)  0/111 (0.00%)  1/184 (0.54%)  0/11 (0.00%) 
Concussion  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
Head Injury  1  1/112 (0.89%)  0/111 (0.00%)  1/184 (0.54%)  0/11 (0.00%) 
Joint sprain  1  0/112 (0.00%)  0/111 (0.00%)  1/184 (0.54%)  0/11 (0.00%) 
Periorbital hematoma  1  0/112 (0.00%)  0/111 (0.00%)  1/184 (0.54%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Brain cancer  1  1/112 (0.89%)  0/111 (0.00%)  0/184 (0.00%)  0/11 (0.00%) 
Liver Cancer  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
Nervous system disorders         
Generalized seizure  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
Grand mal seizure  1  1/112 (0.89%)  0/111 (0.00%)  0/184 (0.00%)  0/11 (0.00%) 
Status epilepticus  1  0/112 (0.00%)  0/111 (0.00%)  0/184 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory failure  1  1/112 (0.89%)  0/111 (0.00%)  0/184 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/112 (0.00%)  1/111 (0.90%)  0/184 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Phase: LTG XR, 300 mg Treatment Phase: LTG XR, 250 mg Continuation Phase: LTG XR, 300 mg Continuation Phase: Baseline Failures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/112 (39.29%)   52/111 (46.85%)   47/184 (25.54%)   4/11 (36.36%) 
Gastrointestinal disorders         
Nausea  1  6/112 (5.36%)  6/111 (5.41%)  6/184 (3.26%)  1/11 (9.09%) 
Infections and infestations         
Nasalpharyngitis  1  7/112 (6.25%)  7/111 (6.31%)  5/184 (2.72%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/112 (0.00%)  0/111 (0.00%)  5/184 (2.72%)  1/11 (9.09%) 
Nervous system disorders         
Dizziness  1  12/112 (10.71%)  10/111 (9.01%)  11/184 (5.98%)  2/11 (18.18%) 
Headache  1  29/112 (25.89%)  31/111 (27.93%)  33/184 (17.93%)  1/11 (9.09%) 
Somnolence  1  5/112 (4.46%)  6/111 (5.41%)  5/184 (2.72%)  1/11 (9.09%) 
Psychiatric disorders         
Insomnia  1  0/112 (0.00%)  5/111 (4.50%)  0/184 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  4/112 (3.57%)  12/111 (10.81%)  0/184 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00355082     History of Changes
Other Study ID Numbers: LAM30055
First Submitted: July 19, 2006
First Posted: July 21, 2006
Results First Submitted: September 8, 2009
Results First Posted: November 25, 2009
Last Update Posted: January 2, 2017