NCT01172379

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (planned)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias.

Detailed description

This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007 or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian treatment. The study will involve two overnight in-patient stays. The first of these will be for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the study will be conducted on an outpatient basis.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	E2007	Experimental 1 Drug: E2007 0.5 mg 1 tablet per day
DRUG	E2007	Experimental 2 Drug: E2007 1.0 mg 1 tablet per day
DRUG	E2007	Drug: E2007 2.0 mg 1 tablet per day
OTHER	Placebo Comparator	Placebo 1 tablet per day

Timeline

• Start date: 2004-05-01
• Primary completion: 2005-02-01
• First posted: 2010-07-29
• Last updated: 2014-08-22

Locations

33 sites across 6 countries: Czechia, France, Germany, Italy, Serbia, Spain