The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations|
- 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.
- 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.
|Study Start Date:||March 2007|
|St. Josef Hospital|
|Bochum, Germany, 44791|
|Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Neurologische Universitatsklinik Marburg|
|Marburg, Germany, D-35039|
|CESI - Centro Ricerche Cliniche - Fondazione Universita degli Studi|
|Chieti, Italy, 66013|
|U.O. Riabilitazione Neuromotoria, IRCCS San Raffaele Pisana|
|Roma, Italy, 00163|
|Study Director:||Alessia Nicotra, M.D., Ph.D.||Eisai Limited|