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NCT00165789 · ClinicalTrials.gov registry record · Phase 2

A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

A Phase 2 study, sponsored by Eisai.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00165789: Completed Phase 2 study, sponsored by Eisai.

NCT00165789 is a Phase 2 study that has completed, run by Eisai. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00165789, a Phase 2 study, has completed, sponsored by Eisai.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

Primary Outcome

Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.

Interventions

  • DRUG E2007

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2005-09
Est. Completion 2006-09
Phase Phase 2
Eisai

287 total trials

What the finished NCT00165789 record still lists

NCT00165789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which E2007 is the first listed.

NCT00165789 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00165789 about?

NCT00165789 is a clinical study titled "A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations". This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

What is the current status of trial NCT00165789?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2005-09. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00165789?

The interventions under investigation include: E2007 (DRUG).

Who is sponsoring clinical trial NCT00165789?

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

How this trial's enrollment target compares

Where NCT00165789's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 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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Source: ClinicalTrials.gov NCT00165789, the US trial registry maintained by the National Library of Medicine. NCT00165789 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.