NCT01457989

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

October 20, 2011

Last Update Submit

October 25, 2012

Conditions

Epilepsy, Partial

Keywords

retention rateepilepsyresponder rateseizure freedomdiscontinuation ratesafety assessmentreduction in seizure frequencyopen-label

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events

    Adverse events were the primary means to assess safety.

    during open-label drug exposure up to database cutoff (max 40 months)

Secondary Outcomes (9)

  • Time to Discontinuation

    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

    for at least 3, 6, 12, 18, 24 and 32 months

  • Listing of abnormal liver function test results and liver adverse events

    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

    baseline (parent study) and at 1, 3, 12, 24 and 36 months

  • Percent change from baseline in seizure frequency

    entire open-label extension period up to database cutoff (max 40 months)

  • +4 more secondary outcomes

Study Arms (1)

retigabine/ezogabine

retigabine/ezogabine; dose range up to 1200 mg/day

Drug: retigabine/ezogabine

Interventions

retigabine/ezogabineDRUG

dose range up to 1200 mg/day

Also known as: Trobalt
retigabine/ezogabine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsies, PartialEpilepsy

Interventions

ezogabine

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 24, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 29, 2012

Record last verified: 2012-10