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NCT00735397 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,218
- Enrollment target
NCT00735397: Completed Phase 3 study, sponsored by Eisai.
NCT00735397 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 1,218 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00735397, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,218 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.
Primary Outcome
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prol
Interventions
- DRUG perampanel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,218 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT00735397 record still lists
NCT00735397 is an interventional study that assigns participants to a tested intervention. Its 1,218 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 1 intervention - of which perampanel is the first listed.
NCT00735397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00735397 about?
NCT00735397 is a clinical study titled "Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures". The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.
What is the current status of trial NCT00735397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,218 participants. The study started on 2008-10. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00735397?
The interventions under investigation include: perampanel (DRUG).
Who is sponsoring clinical trial NCT00735397?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00735397's enrollment target sits among peer trials
1,218 215th of 2000 higher than 1,786 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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