Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 146 for:    epilepsy AND Bethesda

Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00866775
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : February 4, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Epilepsy With Simple or Complex Partial Onset Seizures
Intervention Drug: Eslicarbazepine acetate
Enrollment 193
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Period Title: Overall Study
Started 65 128
Completed 29 76
Not Completed 36 52
Reason Not Completed
Adverse Event             5             19
Death             1             0
Lost to Follow-up             0             4
Physician Decision             0             3
Protocol Violation             3             4
Withdrawal by Subject             4             4
met exit criteria             23             17
discontinued due to communication error             0             1
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD Total
Hide Arm/Group Description

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18. Total of all reporting groups
Overall Number of Baseline Participants 65 128 193
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 128 participants 193 participants
less than 18 years 4 2 6
18-39 years 31 61 92
40-65 years 29 61 90
greater than 65 years 1 4 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 128 participants 193 participants
Female
34
  52.3%
67
  52.3%
101
  52.3%
Male
31
  47.7%
61
  47.7%
92
  47.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 128 participants 193 participants
American Indian or Alsaka Native 0 1 1
Asian 1 3 4
Native Hawaiian or Pacific Islander 0 0 0
Black or African American 4 18 22
White 53 94 147
More than one race 1 0 1
Unknown or Not Reported 6 12 18
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants 128 participants 193 participants
Canada 1 5 6
United States 64 123 187
1.Primary Outcome
Title Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method
Hide Description Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.
Time Frame Week 3 to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.444
(0.3252 to 0.5832)
0.287
(0.2124 to 0.3813)
2.Secondary Outcome
Title Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.
Hide Description Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.
Time Frame Weeks 9 through 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.3
(2.8 to 18.4)
7.6
(3.5 to 14.0)
3.Secondary Outcome
Title Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.
Hide Description Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.
Time Frame Weeks 15 through 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.3
(5.9 to 24.6)
14.4
(8.6 to 22.1)
4.Secondary Outcome
Title Completion Rate
Hide Description Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.
Time Frame Week 1 to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.3
(35.2 to 61.6)
64.4
(55.1 to 73.0)
5.Secondary Outcome
Title Completion Rate During the 10 Weeks of Monotherapy
Hide Description Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.
Time Frame Weeks 8 through 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 45 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.4
(48.8 to 78.1)
81.7
(72.4 to 89.0)
6.Secondary Outcome
Title Time on Eslicarbazepine Acetate Monotherapy.
Hide Description The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.
Time Frame Week 8 to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
median not calculable due to lack of events
7.Secondary Outcome
Title Change in Seizure Frequency From Baseline.
Hide Description The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).
Time Frame Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population (ESL 1200 mg) Double-blind: 60;Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Titration: 118; AED taper/conversion:114; Monotherapy:93
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Median (Inter-Quartile Range)
Unit of Measure: percent change
Relative (%) change from baselne for DB period
-30.9
(-63.3 to 30.9)
-41.5
(-65.6 to -9.5)
Relative (%) change from baseline -tiration period
-29.6
(-100.0 to 1.8)
-52.4
(-100.0 to -11.4)
Relative (%) change from baseline -AED t/c period
-30.2
(-69.5 to 25.9)
-39.7
(-78.3 to 1.6)
Relative (%) change from baseline - mono period
-48.7
(-73.2 to 43.3)
-38.6
(-77.1 to -7.9)
8.Secondary Outcome
Title Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
Hide Description Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.
Time Frame Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Responder rate during double blind period
36.7
(24.6 to 50.1)
39.8
(30.9 to 49.3)
Responder rate during the titration period
46.7
(33.7 to 60.0)
51.7
(42.3 to 61.0)
Responder Rate during the AED T/C period
41.7
(29.1 to 55.1)
43.2
(34.1 to 52.7)
Responder rate during monotherapy period
35.0
(23.1 to 48.4)
32.2
(23.9 to 41.4)
9.Secondary Outcome
Title Percentage of Subjects Reaching Each of the Exit Events.
Hide Description The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.
Time Frame Week 1 to Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Measure Type: Number
Unit of Measure: percentage of participants
exit criterion 1 0 0.8
exit criterion 2 6.7 0.8
exit criterion 3 (investigator prog. assessment) 10.0 4.2
exit criterion 3 (sponsors prog. assessment) 8.3 5.9
exit criterion 4 (investigaor prog. assessment) 8.3 5.1
exit criterion 4 (sponsor prog. assessment) 10.0 5.9
exit criterion 5 13.3 3.4
10.Secondary Outcome
Title Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
Hide Description The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.
Time Frame Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Hide Outcome Measure Data
Hide Analysis Population Description
the numbers analyzed represent all participants for whom data were available at baseline (ESL 1200 mg)Change from baseline to end of AED taper/conversion period: 39;Change from baseline to end of monotherapy period:36 (ESL1600 mg) Change from baseline to end of AED taper/conversion period: 86;Change from baseline to end of monotherapy period: 86
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 54 113
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline to end of AED T/C pd n=39,86 3.2  (10.75) 6.3  (12.42)
change from baseline to end of mono. pd n=36,86 7.8  (13.78) 6.4  (12.64)
11.Secondary Outcome
Title Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
Hide Description The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity
Time Frame Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversion period: 45; Change from baseline to end of monotherapy period: 41 (ESL 1600 mg) Change from baseline to end of AED taper/conversion period: 92; Change from baseline to end of monotherapy period: 91
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 60 118
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline to AED T/C period -0.4  (4.35) -2.0  (5.99)
Change from baseline to end of mono period -1.1  (5.55) -2.4  (5.77)
12.Secondary Outcome
Title Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.
Hide Description The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity
Time Frame Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population (ESL 1200 mg) Change from baseline to end of AED taper/conversation period: 7; Change from baseline to end of monotherapy period: 6 (ESL 1600 mg) Change from baseline to end of AED taper/conversation period: 13; Change from baseline to end of monotherapy period: 13
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 9 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from baseline to AED T/C pd n=7,13 -1.3  (3.86) -7.9  (9.81)
Change from baseline to end of mono pd n=6,13 -6.8  (6.71) -9.6  (8.72)
13.Secondary Outcome
Title Percentage of Subjects With Increase of Body Weight >= 7%
Hide Description [Not Specified]
Time Frame 18 Week Double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 65 128
Measure Type: Number
Unit of Measure: Percentage of participants
2 9
14.Secondary Outcome
Title Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Hide Description Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Time Frame 18 Week Double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 65 128
Measure Type: Number
Unit of Measure: Percent
≤ 135 and > 130 mEq/L 29 61
≤ 13- amd > 125 mEq/L 6 11
≤125 mEq/L 3 5
15.Secondary Outcome
Title Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
Hide Description [Not Specified]
Time Frame 18 Week Double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 65 128
Measure Type: Number
Unit of Measure: Percent of participants
Actual Attempt 0 0
Non-suicidal Self-Injurious Behavior 0 0
Interrupted Attempt 1.5 0
Aborted Attempt 0 0
Preparatory Attempts 1.5 0
SuicidalBehavior 0 0
Wish to be Dead 4.6 3.1
Non-specific Active Suicidal Thoughts 4.6 0.8
Act. Suicidal Idea. w/any method-no intent to act 1.5 0.8
Act. Suicidal Idea.w/any method-some intent to act 0 0
Act. Suicidal Idea. w/any method-Spec. Plan to act 0 0
16.Secondary Outcome
Title Standardized Seizure Frequency (SSF) by Period
Hide Description Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).
Time Frame Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18
Hide Outcome Measure Data
Hide Analysis Population Description
efficacy population (ESL 1200 mg) Double-blind: 60; Baseline: 60; Titration: 60; AED taper/conversion: 60; Monotherapy: 43 (ESL 1600 mg) Double-blind: 118; Baseline: 118; Titration: 118; AED taper/conversion: 114; Monotherapy: 93
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description:

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
Overall Number of Participants Analyzed 65 128
Mean (Standard Deviation)
Unit of Measure: Number of seizures in 28 days
SSF during double-blind period 8.8  (12.89) 6.9  (6.50)
SSF during baseline 8.7  (5.63) 10.9  (7.70)
SSF during titration period 6.2  (7.77) 6.4  (7.53)
SSF during AED taper/conversion period 8.7  (14.78) 6.9  (6.90)
SSF during monotherapy period 13.2  (29.52) 6.8  (7.65)
Time Frame 18 weeks double-blind treatment period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Hide Arm/Group Description

Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.

.

Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
All-Cause Mortality
Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/65 (6.15%)      8/128 (6.25%)    
Cardiac disorders     
cardiogenic shock  1/65 (1.54%)  1 0/128 (0.00%)  0
Gastrointestinal disorders     
Nausea  0/65 (0.00%)  0 1/128 (0.78%)  1
vomiting  0/65 (0.00%)  0 1/128 (0.78%)  1
General disorders     
Oedema peripheral  1/65 (1.54%)  1 0/128 (0.00%)  0
Injury, poisoning and procedural complications     
Accidnetal overdose  0/65 (0.00%)  0 1/128 (0.78%)  1
Multiple injuries  1/65 (1.54%)  1 0/128 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1/65 (1.54%)  1 0/128 (0.00%)  0
Hyponatraemia  0/65 (0.00%)  0 2/128 (1.56%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic neoplasm  1/65 (1.54%)  1 0/128 (0.00%)  0
Nervous system disorders     
Cerebral cyst  0/65 (0.00%)  0 1/128 (0.78%)  1
complex partial seizers  0/65 (0.00%)  0 1/128 (0.78%)  1
Hypoaesthesia  0/65 (0.00%)  0 1/128 (0.78%)  1
Partial seizures with secondary generalisation  1/65 (1.54%)  1 0/128 (0.00%)  0
Status epilepticus  0/65 (0.00%)  0 1/128 (0.78%)  1
Psychiatric disorders     
Anxiety  0/65 (0.00%)  0 1/128 (0.78%)  1
Depression  0/65 (0.00%)  0 1/128 (0.78%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  0/65 (0.00%)  0 1/128 (0.78%)  1
Pulmonary oedema  1/65 (1.54%)  1 0/128 (0.00%)  0
Vascular disorders     
Hypertension  0/65 (0.00%)  0 1/128 (0.78%)  1
1
Term from vocabulary, MedDRA version 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eslicarbazepine 1200 mg QD Eslicarbazepine 1600 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/65 (70.77%)      100/128 (78.13%)    
Eye disorders     
Diplopia  5/65 (7.69%)  5 6/128 (4.69%)  6
Vision blurred  6/65 (9.23%)  6 12/128 (9.38%)  15
Gastrointestinal disorders     
Abdominal discomfort  4/65 (6.15%)  6 4/128 (3.13%)  4
Diarrhoea  5/65 (7.69%)  6 9/128 (7.03%)  12
Nausea  7/65 (10.77%)  9 18/128 (14.06%)  28
Toothache  4/65 (6.15%)  4 1/128 (0.78%)  1
Vomiting  6/65 (9.23%)  7 11/128 (8.59%)  14
General disorders     
Fatigue  13/65 (20.00%)  14 20/128 (15.63%)  25
Infections and infestations     
Gastroenteritis viral  4/65 (6.15%)  4 4/128 (3.13%)  4
Influenza  4/65 (6.15%)  4 5/128 (3.91%)  5
Nasopharyngitis  7/65 (10.77%)  7 14/128 (10.94%)  15
Injury, poisoning and procedural complications     
Confusion  4/65 (6.15%)  4 7/128 (5.47%)  8
Fall  4/65 (6.15%)  5 3/128 (2.34%)  3
Metabolism and nutrition disorders     
Hyponatraemia  4/65 (6.15%)  6 8/128 (6.25%)  9
Musculoskeletal and connective tissue disorders     
Back pain  10/65 (15.38%)  11 6/128 (4.69%)  6
Pain in extremity  5/65 (7.69%)  6 2/128 (1.56%)  2
Nervous system disorders     
Dizziness  18/65 (27.69%)  31 31/128 (24.22%)  42
Headache  14/65 (21.54%)  28 26/128 (20.31%)  33
Memory impariment  5/65 (7.69%)  5 2/128 (1.56%)  2
Partial seizures with secondary generalisation  6/65 (9.23%)  6 1/128 (0.78%)  1
Somnolence  7/65 (10.77%)  8 23/128 (17.97%)  33
Psychiatric disorders     
Insomnia  3/65 (4.62%)  3 8/128 (6.25%)  9
1
Term from vocabulary, MedDRA version 13.1
The comparison of active treatment to control which was used in this trial is based on a pooled analysis of comparator groups from 8 earlier trials of similar design. Limitations related to use of historical control groups are applicable.
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.
In the event the Study is part of a multi-center study, the first publication of the results of the study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eslicarbazepine acetate Medical Director
Organization: Sunovion Phamaceuticals Inc.
Phone: 866-503-7813
EMail: clinicaltrialsdisclosure@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00866775     History of Changes
Other Study ID Numbers: 093-045
First Submitted: March 18, 2009
First Posted: March 20, 2009
Results First Submitted: October 6, 2015
Results First Posted: February 4, 2016
Last Update Posted: March 11, 2016