Clinical trial NCT01457989: Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Partial
Keywords: retention rate
epilepsy
responder rate
seizure freedom
discontinuation rate
safety assessment
reduction in seizure frequency
open-label
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: This is meta-analysis therefore Inclusion/Exclusion criteria are not applicable.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: during open-label drug exposure up to database cutoff (max 40 months)
Secondary outcomes:
measure: Time to Discontinuation
timeFrame: during open-label extension up to date of discontinuation; subjects who continue in the study are censored at database cutoff (max 40 months)
measure: The number and percent of subjects exposed to study drug
timeFrame: for at least 3, 6, 12, 18, 24 and 32 months
measure: Listing of abnormal liver function test results and liver adverse events
timeFrame: during open-label drug exposure up to database cutoff (max 40 months)
measure: Observed values and change from baseline summaries for American Urological Association symptom index scores, Post-Void Residual bladder ultrasound, Vital Signs and Weight
timeFrame: baseline (parent study) and at 1, 3, 12, 24 and 36 months
measure: Percent change from baseline in seizure frequency
timeFrame: entire open-label extension period up to database cutoff (max 40 months)
measure: Number and percent of responders
timeFrame: entire open-label extension period up to database cutoff (max 40 months)
measure: Number and percent of seizure free subjects
timeFrame: during open-label drug exposure up to database cutoff (max 40 months)
measure: Proportion of subjects retained in the study
timeFrame: at 3, 6, 12, 24 and 32 months after exposure to first dose in open-label extension study.
measure: Mean of average dose
timeFrame: entire open-label drug extension period up to database cutoff (max 40 months)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: