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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00451633 |
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 | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: E2007 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study |
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 |
Estimated Enrollment: | 24 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patients will be eligible for the study if they meet all of the following inclusion criteria. Eligibility will be checked at screening and re-confirmed before the start of investigational drug dosing on Day -1 (ie, after completion and review of pre-dosing patient diaries and baseline assessments).
Consistently experiencing clinically-relevant, peak-effect levodopa-induced dyskinesias during the 'on' period following the morning dose of levodopa. Patients should:
Consistently experiencing end-of-dose motor fluctuations. Patients should:
EXCLUSION CRITERIA:
Patients who meet any of the following exclusion criteria will not eligible for the study.
Eligibility will be checked at the Screening visit and re-confirmed before the start of investigational drug dosing on Day -1 (i.e., after completion and review of pre-dosing patient diaries and baseline assessments). All exclusion criteria must be observed.
Germany | |
Neurologische Universitatsklinik Marburg | |
Marburg, Germany, D-35039 | |
St. Josef Hospital | |
Bochum, Germany, 44791 | |
Medizinische Hochschule Hannover | |
Hannover, Germany, 30625 | |
Italy | |
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 |
Study ID Numbers: | E2007-E044-213 |
Study First Received: | March 21, 2007 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00451633 |
Health Authority: | European Union: European Medicines Agency |
Signs and Symptoms Levodopa Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Neurologic Manifestations Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases Dyskinesias |
Nervous System Diseases |