ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 92 of 146 for:    epilepsy AND Bethesda

Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy (RESTORE2)

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: NCT00235755
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : November 7, 2011
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
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: Seizures
Interventions: Drug: Retigabine
Drug: Placebo

  Participant Flow

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 Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
Retigabine 200 mg TID Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
Retigabine 300 mg TID Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.

Participant Flow for 2 periods

Period 1:   4-Week Titration Phase
    Placebo   Retigabine 200 mg TID   Retigabine 300 mg TID
STARTED   179   181   179 
COMPLETED   168   162   153 
NOT COMPLETED   11   19   26 
Adverse Event                6                14                20 
Lost to Follow-up                0                1                1 
Protocol Violation                2                2                1 
Withdrawal by Subject                1                2                3 
Participant Did Not Receive Study Drug                0                0                1 
Randomization Occurred in Error                1                0                0 
Prolonged QT Interval at Visit 3                1                0                0 

Period 2:   12-Week Maintenance Phase
    Placebo   Retigabine 200 mg TID   Retigabine 300 mg TID
STARTED   168   162   153 
COMPLETED   152   135   122 
NOT COMPLETED   16   27   31 
Adverse Event                8                12                26 
Lost to Follow-up                2                3                0 
Lack of Efficacy                5                0                0 
Protocol Violation                0                4                2 
Withdrawal by Subject                0                8                3 
Abnormal Electrocardiogram Test Result                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
Total Total of all reporting groups

Baseline Measures
   Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)   Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)   Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)   Total 
Overall Participants Analyzed 
[Units: Participants]
 179   181   178   538 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37.7  (11.75)   37.5  (12.02)   37.7  (12.77)   37.6  (12.16) 
[1] Baseline characteristics are summarized for the Safety Population, comprised of all participants who were randomized and received at least one dose of study medication.
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      90  50.3%      105  58.0%      85  47.8%      280  52.0% 
Male      89  49.7%      76  42.0%      93  52.2%      258  48.0% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Caucasian   169   173   170   512 
African-American (black)   2   2   1   5 
Asian   3   0   2   5 
Mixed Race   5   6   5   16 


  Outcome Measures

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), DB Phase (Week 1 through Week 16) ]

2.  Primary:   Number of Participants Classified as Responders and Non-responders During the Maintenance Phase   [ Time Frame: Week 5 through Week 16 ]

3.  Secondary:   Number of Participants Who Were Responders and Non-responders During the DB Phase   [ Time Frame: Week 1 through Week 16 ]

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 5 through Week 16 ]

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 16 ]

6.  Secondary:   Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to 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 16 ]

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 5 through Week 16 ]

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 5 through Week 16 ]

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 16 ]

10.  Secondary:   Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)   [ Time Frame: Week 1 through Week 16 ]

11.  Secondary:   Number of Participants Who Were Seizure-free During the Maintenance Phase   [ Time Frame: Week 5 through Week 16 ]

12.  Secondary:   Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)   [ Time Frame: Week 1 through Week 16 ]

13.  Secondary:   Percentage of Seizure-free Days During the Maintenance Phase   [ Time Frame: Week 5 through Week 16 ]

14.  Secondary:   Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase   [ Time Frame: Week 16/end of treatment phase ]

15.  Secondary:   Patient Global Impression (PGI) Score at the End of the Maintenance Phase   [ Time Frame: Week 16/end of treatment phase ]

16.  Secondary:   Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16   [ Time Frame: End of Baseline (Week 0), Weeks 4, 8, and 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 16 ]

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 16 ]

19.  Secondary:   Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase   [ Time Frame: Baseline (Week -7 through 0), Weeks 8 and 16 ]

20.  Secondary:   Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase   [ Time Frame: Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00235755     History of Changes
Other Study ID Numbers: VRX-RET-E22-302
First Submitted: October 6, 2005
First Posted: October 10, 2005
Results First Submitted: July 7, 2011
Results First Posted: November 7, 2011
Last Update Posted: April 21, 2017