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Study Results
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Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy (RESTORE1)
This study has been completed.
Study NCT00232596   Information provided by GlaxoSmithKline

First Received on September 30, 2005.   Last Updated on March 15, 2012   History of Changes
Results First Received: July 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Partial-Onset Seizures
Interventions: Drug: Retigabine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who completed the Double-blind Phase (Titration plus Maintenance Phases) who elected to continue in the Open-Label Extension Study (OLE-S) entered the Transition Phase, for titration, if on placebo, or to maintain the blind if on retigabine. Participants who did not enter the Titration Phase entered a Taper Phase.

Reporting Groups
  Description
Placebo Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
Retigabine Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.

Participant Flow for 2 periods

 Period 1:   6-Week Titration Phase
    Placebo     Retigabine  
STARTED     152     154  
COMPLETED     138     125  
NOT COMPLETED     14     29  
Adverse Event                 6                 19  
Failed to Return                 2                 1  
Unsatisfactory Response - Efficacy                 1                 2  
Protocol Violation                 1                 3  
Participant Request Unrelated to Study                 1                 0  
Unknown                 3                 3  
Participant Did Not Receive Study Drug                 0                 1  

Period 2:   12-Week Maintenance Phase
    Placebo     Retigabine  
STARTED     138     125  
COMPLETED     126 [1]   97  
NOT COMPLETED     12     28  
Adverse Event                 7                 22  
Unsatisfactory Response -Efficacy                 1                 2  
Protocol Violation                 3                 1  
Unknown                 1                 3  
[1] One participant withdrew after being considered a “completer” and is listed as an early withdraw.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo - Double-blind (DB) Phase (Titration + Maintenance) Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
Retigabine - DB Phase (Titration + Maintenance) Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])

Baseline Measures
    Placebo - Double-blind (DB) Phase (Titration + Maintenance)     Retigabine - DB Phase (Titration + Maintenance)     Total  
Number of Participants  
[units: participants]
 		  152     153     305  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  36.7  ± 11.63     37.7  ± 12.55     37.2  ± 12.09  
Gender [1]
[units: Participants]
 		     
Female     80     85     165  
Male     72     68     140  
Race/Ethnicity, Customized [1]
[units: participants]
 		     
Caucasian     78     90     168  
African - American (Black)     15     15     30  
Hispanic     48     39     87  
Asian     1     1     2  
American Indian     1     0     1  
Mestizo     1     0     1  
Mixed Race     8     8     16  
[1] Baseline characteristics were collected in the Safety Population, comprised of all participants who received at least one dose of study medication. One participant randomized to the Retigabine group did not receive study medication in the 6-week Titration Phase.



  Outcome Measures
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1.  Primary:   Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)   [ Time Frame: Baseline (Week -7 through Week 0), Week 1 through Week 18 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Who Were Responders and Non-responders in the Maintenance Phase   [ Time Frame: Week 7 through Week 18 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Who Were Responders and Non-responders in the DB Phase   [ Time Frame: Week 1 through Week 18 ]
  Show Outcome Measure 3

4.  Secondary:   Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase   [ Time Frame: Baseline (Week -7 through Week 0), Week 7 through Week 18 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories   [ Time Frame: Baseline (Week -7 through Week 0), Week 1 through Week 18 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories   [ Time Frame: Baseline (Week -7 through Week 0), Week 1 through Week 18 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase   [ Time Frame: Baseline (Week -7 through Week 0), Week 7 through Week 18 ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase   [ Time Frame: Baseline (Week -7 through Week 0), Week 7 through Week 18 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline   [ Time Frame: Baseline (Week -7 through Week 0), Week 1 through Week 18 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)   [ Time Frame: Week 1 through Week 18 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants Who Were Seizure-free During the Maintenance Phase   [ Time Frame: Week 7 through Week 18 ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)   [ Time Frame: Week 1 through Week 18 ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Seizure-free Days During the Maintenance Phase   [ Time Frame: Week 7 through Week 18 ]
  Show Outcome Measure 13

14.  Secondary:   Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase   [ Time Frame: Week 18/end of treatment phase ]
  Show Outcome Measure 14

15.  Secondary:   Patient Global Impression (PGI) Score at the End of the Maintenance Phase   [ Time Frame: Week 18/end of treatment phase ]
  Show Outcome Measure 15

16.  Secondary:   Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18   [ Time Frame: End of Baseline (Week 0), Weeks 6, 10, and 18 ]
  Show Outcome Measure 16

17.  Secondary:   Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)   [ Time Frame: Week 1 through Week 24 ]
  Show Outcome Measure 17

18.  Secondary:   Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)   [ Time Frame: Week 1 through Week 24 ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase   [ Time Frame: Baseline (Week -7 through Week 0), Weeks 10 and 18 ]
  Show Outcome Measure 19

20.  Secondary:   Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase   [ Time Frame: Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase ]
  Show Outcome Measure 20


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00232596     History of Changes
Other Study ID Numbers: VRX-RET-E22-301
Study First Received: September 30, 2005
Results First Received: July 7, 2011
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration





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