- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01457989
Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304
October 25, 2012 updated by: GlaxoSmithKline
Meta-Analysis of VRX-RET-E22-303 and VRX-RET-E22-304: Two Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Studies of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extensions of Studies VRX-RET-E22-301 and VRX-RET-E22-302)
The objective of this meta-analysis is to provide data on long-term safety and efficacy following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion for retigabine using pooled data from ongoing open-label extension (OLE) Studies VRX-RET-E22-303 and VRX-RET-E22-304.
Study Overview
Detailed Description
Data from the October 2009 data-cut of ongoing Studies VRX-RET-E22-303 (Study 303) and VRX-RET-E22-304 (Study 304) will be pooled, summarized, and published with the goal of providing updated long-term safety and efficacy information for subjects and prescribers following the recent positive CHMP opinion for retigabine for adjunctive use in patients with partial seizures.
Studies 303 and 304 are the open-label extensions of two Phase 3 studies (VRX-RET-E22-301 and VRX-RET-E22-302), respectively.
Studies 301 and 302 were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg per day (Study 302) and 1200 mg per day (Study 301).
All subjects who wished to enter the OLE studies and, in the opinion of the investigator, were expected to benefit from participation in the OLEs, entered a 6-week (Study 301) or 4-week (Study 302) transition phase in which their dose of retigabine was titrated to or maintained at 400 mg TID (Study 301) or 300 mg TID (Study 302).
Upon completion of the Transition phase, subjects enrolled into the extension studies.
Once enrolled in the OLE, doses could be adjusted within the range of 600 mg to 1200 mg per day.
Treatment in Studies 303 and 304 is planned to continue until regulatory approval and commercialization of retigabine or until the program is discontinued.
Study Type
Observational
Enrollment (Actual)
1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with partial onset seizures who have successfully completed the transition phase of VRX-RET-E22-301 and VRX-RET-E22-302.
Description
This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
retigabine/ezogabine
retigabine/ezogabine; dose range up to 1200 mg/day
|
dose range up to 1200 mg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events
Time Frame: during open-label drug exposure up to database cutoff (max 40 months)
|
Adverse events were the primary means to assess safety.
|
during open-label drug exposure up to database cutoff (max 40 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Discontinuation
Time Frame: during open-label extension up to date of discontinuation; subjects who continue in the study are censored at database cutoff (max 40 months)
|
Time to discontinuation in number of days since first dose in open-label extension until subject discontinues
|
during open-label extension up to date of discontinuation; subjects who continue in the study are censored at database cutoff (max 40 months)
|
The number and percent of subjects exposed to study drug
Time Frame: for at least 3, 6, 12, 18, 24 and 32 months
|
The number and percent of subjects exposed to study drug
|
for at least 3, 6, 12, 18, 24 and 32 months
|
Listing of abnormal liver function test results and liver adverse events
Time Frame: during open-label drug exposure up to database cutoff (max 40 months)
|
Abnormal lab results if reported as adverse events or values of alkaline phosphatase, alanine transaminase, aspartate transaminase [>3, >5, >10xupper limit of normal (ULN)] or total bilirubin (>1.5, >2, >4xULN); treatment emergent adverse events related to liver function test abnormalities
|
during open-label drug exposure up to database cutoff (max 40 months)
|
Observed values and change from baseline summaries for American Urological Association symptom index scores, Post-Void Residual bladder ultrasound, Vital Signs and Weight
Time Frame: baseline (parent study) and at 1, 3, 12, 24 and 36 months
|
Univariate statistics summarizing the observed values and change from baseline, using parent study baseline value
|
baseline (parent study) and at 1, 3, 12, 24 and 36 months
|
Percent change from baseline in seizure frequency
Time Frame: entire open-label extension period up to database cutoff (max 40 months)
|
Percent change from baseline in 28-day total partial seizure frequency, using parent study baseline value.
|
entire open-label extension period up to database cutoff (max 40 months)
|
Number and percent of responders
Time Frame: entire open-label extension period up to database cutoff (max 40 months)
|
Number and percent of responders (defined as subjects with >=50% reduction from baseline in 28-day total partial seizure frequency) using parent study baseline value
|
entire open-label extension period up to database cutoff (max 40 months)
|
Number and percent of seizure free subjects
Time Frame: during open-label drug exposure up to database cutoff (max 40 months)
|
Percent of subjects seizure free for any 6 continuous months or longer for subjects treated for at least 6, 12 and 24 months; percent of seizure free subjects for any 12 continuous months or longer for subjects treated for at least 12 and 24 months
|
during open-label drug exposure up to database cutoff (max 40 months)
|
Proportion of subjects retained in the study
Time Frame: at 3, 6, 12, 24 and 32 months after exposure to first dose in open-label extension study.
|
Length of time subjects retained in OLE as summarized by proportion of subjects remaining in both studies at given timepoints.
|
at 3, 6, 12, 24 and 32 months after exposure to first dose in open-label extension study.
|
Mean of average dose
Time Frame: entire open-label drug extension period up to database cutoff (max 40 months)
|
Mean average dose for all subjects combined and by modal dose category [the range of doses (<=750 mg/day, >750 to 1050 mg/day, >1050 mg/day) taken most frequently].
|
entire open-label drug extension period up to database cutoff (max 40 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
October 20, 2011
First Submitted That Met QC Criteria
October 20, 2011
First Posted (ESTIMATE)
October 24, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 29, 2012
Last Update Submitted That Met QC Criteria
October 25, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 115476
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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