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

Phase 3

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00286897
• Lead Sponsor: Eisai Limited

Brief Summary

Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-03
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-06
• Primary Completion: 2007-06
• Study Completion: 2007-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).

Secondary Outcome Measures

Name	Time	Method
Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias.

Trial Locations

Locations (105)

University Clinic Innsbruck; 🇦🇹 Innsbruck, Austria

Department of Neurology; 🇦🇹 Vienna, Austria

Cliniques Universitaires St-Luc; 🇧🇪 Brussels, Belgium

C.H.U.de Charleroi; 🇧🇪 Charleroi, Belgium

U.Z. Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Gent; 🇧🇪 Gent, Belgium

C.H.R. de la Citadelle; 🇧🇪 Liege, Belgium

Hopital St-Pierre; 🇧🇪 Ottignies, Belgium

St-Andries Ziekenhuis; 🇧🇪 Tielt, Belgium

University Hospital; 🇨🇿 Ostrava, Czech Republic

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