CompletedPhase 3

Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

United States, Argentina, Brazil181 participantsStarted 2006-05-01

Plain-language summary

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures * Patient is expected to benefit from participation in the study in the opinion of the Investigator. Exclusion Criteria: * Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event. * Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition. * Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)

Timeframe: Assessed up to a maximum of 9 years

Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug

Timeframe: Assessed up to a maximum of 9 years

Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug

Timeframe: Assessed up to a maximum of 9 years

Change From Baseline in Blood Pressure

Timeframe: Baseline and Up to Month 108

Change From Baseline in Heart Rate

Timeframe: Baseline and Up to Month 108

Change From Baseline in Body Temperature

Timeframe: Baseline and Up to Month 108

Change From Baseline in Weight

Timeframe: Baseline and Up to Month 108

Trial details

NCT IDNCT00310375

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-30

Results submitted2016-07-27

View on ClinicalTrials.gov More Epilepsy trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)

Timeframe: Assessed up to a maximum of 9 years

Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug

Timeframe: Assessed up to a maximum of 9 years

Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug

Timeframe: Assessed up to a maximum of 9 years

Change From Baseline in Blood Pressure

Timeframe: Baseline and Up to Month 108

Change From Baseline in Heart Rate

Timeframe: Baseline and Up to Month 108

Change From Baseline in Body Temperature

Timeframe: Baseline and Up to Month 108

Change From Baseline in Weight

Timeframe: Baseline and Up to Month 108