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NCT00232596 · ClinicalTrials.gov registry record · Phase 3
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
A Phase 3 study of Seizures, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 306
- Enrollment target
- 20
- Study locations
NCT00232596: Completed Phase 3 study of Seizures, sponsored by GlaxoSmithKline.
NCT00232596 is a Phase 3 study of Seizures that has completed, run by GlaxoSmithKline. The registered enrollment target is 306 participants, below the 927-participant average among 39 other Seizures trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00232596, a Phase 3 study of Seizures, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 306 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
Primary Outcome
28-day total PS (PSs \[also called focal seizures\] are seizures limited to a specific area of the brain) frequency in the BL period = (Number \[No.\] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = (\[value in the DB period minus value
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Retigabine
Study Locations (20)
Alabama
- University of Alabama -- Department of Neurology/Epilepsy Center - Birmingham
- North Alabama Neuroscience Research Associates - Huntsville
- Neurology Clinic - Northport
California
- UCSD Thornton Hospital - La Jolla
- University of Southern California - Los Angeles
- West Los Angeles VA Healthcare Center - Los Angeles
Florida
- University of Florida -- Shands Jacksonville - Jacksonville
- University of Miami - Miami
- Lovelace Scientific Resources - Sarasota
Colorado
- Delta Waves - Colorado Springs
- University of Colorado Health Science Center - Denver
Arizona
- Barrow Neurological Institute - Phoenix
Arkansas
- Clinical Trials Inc. - Little Rock
Iowa
- McFarland Clinic - Ames
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00232596 record still lists
NCT00232596 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, below the 927-participant average among 39 other Seizures trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00232596 names 20 study sites across 13 states, led by Alabama, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00232596 about?
NCT00232596 is a clinical study titled "Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy". This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
What is the current status of trial NCT00232596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 306 participants. The study started on 2005-09. Estimated completion is 2008-01.
What conditions does trial NCT00232596 study?
This clinical trial studies the following conditions: Seizures.
What interventions are being tested in trial NCT00232596?
The interventions under investigation include: Placebo (DRUG), Retigabine (DRUG).
Who is sponsoring clinical trial NCT00232596?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00232596 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Seizures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00232596's enrollment target sits among peer trials
306 11th of 39 higher than 29 of 39 other Seizures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seizures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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