NCT00427011

A Study of E2007 In Patients With Parkinson's Disease

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose "Wearing-Off" Motor Fluctuations

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Parkinson's Disease

Interventions

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

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-01-26
• Last updated: 2013-02-11
• Results posted: 2013-02-05

Locations

9 sites across 1 country: United States