The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
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|ClinicalTrials.gov Identifier: NCT00451633|
Recruitment Status : Withdrawn (The study group changed from patients to a healthy volunteers. A healthy-volunteer study is being planned to replace 213.)
First Posted : March 23, 2007
Last Update Posted : October 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: E2007||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||March 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451633
|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|