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A Study of E2007 In Patients With Parkinson's Disease

NCT00427011 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-02-11

Study results available
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Summary

Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 \[Visit 2\] through Week 12 \[Visit 7\]) followed by the Maintenance Phase (from Week 12 \[Visit 7\] to end of study).

Conditions

Interventions

DRUG

E2007

E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • David Squillacote, MD · Eisai Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00427011 on ClinicalTrials.gov