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NCT00368108 · ClinicalTrials.gov registry record · Phase 3

Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

A Phase 3 study, sponsored by Eisai.

Completed
Registry status
Phase 3
Development phase
752
Enrollment target

NCT00368108: Completed Phase 3 study, sponsored by Eisai.

NCT00368108 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 752 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00368108, a Phase 3 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 3
Development phase
752 participants
Enrollment target

Study Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.

Primary Outcome

Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.

Interventions

  • DRUG placebo comparator
  • DRUG 2 mg perampanel
  • DRUG 4 mg perampanel

Trial Details

FieldValue
Enrollment Target 752 participants
Start Date 2006-08
Est. Completion 2008-01
Phase Phase 3
Eisai

287 total trials

What the finished NCT00368108 record still lists

NCT00368108 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which placebo comparator is the first listed.

NCT00368108 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00368108 about?

NCT00368108 is a clinical study titled "Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations". This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.

What is the current status of trial NCT00368108?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2006-08. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00368108?

The interventions under investigation include: placebo comparator (DRUG), 2 mg perampanel (DRUG), 4 mg perampanel (DRUG).

Who is sponsoring clinical trial NCT00368108?

This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00368108's enrollment target sits among peer trials

752 460th of 2000 higher than 1,539 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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Source: ClinicalTrials.gov NCT00368108, the US trial registry maintained by the National Library of Medicine. NCT00368108 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.