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NCT01161524 · ClinicalTrials.gov registry record · Phase 2
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
A Phase 2 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
NCT01161524: Completed Phase 2 study, sponsored by Eisai.
NCT01161524 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 133 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161524, a Phase 2 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
Study Summary
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.
Primary Outcome
The CDR System Global Cognitive score was derived from the average of 5 CDR System cognitive domain scores (Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory). The domain scores were normalized to mean of 50 and standard deviation of 10 before taking the average. The scale ranged from 0 - 100. An increase in the Global Cognitive Score indicates improvement, while a decrease indicates worsening in cognitive function.
Interventions
- DRUG Placebo
- DRUG Perampanel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-11 |
| Phase | Phase 2 |
What the finished NCT01161524 record still lists
NCT01161524 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01161524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01161524 about?
NCT01161524 is a clinical study titled "A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents". This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.
What is the current status of trial NCT01161524?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2010-09. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01161524?
The interventions under investigation include: Placebo (DRUG), Perampanel (DRUG).
Who is sponsoring clinical trial NCT01161524?
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 NCT01161524's enrollment target sits among peer trials
133 538th of 2000 higher than 1,462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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