Skip to main content
OpenTrials
Completed

NCT Number: NCT01457989

Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retigabine/ezogabine

Drug

dose range up to 1200 mg/day

Other names: Trobalt

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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].

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 24, 2011
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.