The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00451633
- Lead Sponsor
- Eisai Inc.
- Brief Summary
A randomized, double blind, placebo-controlled study employing a mixed parallel group and fixed sequence cross-over design.
Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will be escalated to 4 mg E2007 o.d. after three weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Levodopa pharmacokinetics will be assessed after each levodopa challenge. Blood samples for measurement of levodopa plasma concentrations will be taken before and after levodopa dosing or until a full 'off' state is reached if earlier than 5 h.
- Secondary Outcome Measures
Name Time Method Pharmacodynamic assessments of dyskinesias and motor function; Goetz/Rush dyskinesia rating scale; modified abnormal involuntary movement scale (AIMS), and Unified Parkinson's disease rating scale motor examination sub-scale (UPDRS Part 3) scores.
Trial Locations
- Locations (5)
St. Josef Hospital
🇩🇪Bochum, Germany
U.O. Riabilitazione Neuromotoria, IRCCS San Raffaele Pisana
🇮🇹Roma, Italy
CESI - Centro Ricerche Cliniche - Fondazione Universita degli Studi
🇮🇹Chieti, Italy
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Neurologische Universitatsklinik Marburg
🇩🇪Marburg, Germany