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NCT00310375 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 181
- Enrollment target
NCT00310375: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00310375 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 181 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00310375, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 181 participants
- Enrollment target
Study 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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defi
Interventions
- DRUG Ezogabine: USAN Retigabine (International Nonproprietary Name)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2017-03-15 |
| Phase | Phase 3 |
What the finished NCT00310375 record still lists
NCT00310375 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Ezogabine: USAN Retigabine (International Nonproprietary Name) is the first listed.
NCT00310375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00310375 about?
NCT00310375 is a clinical study titled "Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial". 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 retigabi...
What is the current status of trial NCT00310375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 181 participants. The study started on 2006-05-01. Estimated completion is 2017-03-15.
What interventions are being tested in trial NCT00310375?
The interventions under investigation include: Ezogabine: USAN Retigabine (International Nonproprietary Name) (DRUG).
Who is sponsoring clinical trial NCT00310375?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00310375's enrollment target sits among peer trials
181 1422nd of 2000 higher than 579 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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