The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias.
This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007 or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian treatment. The study will involve two overnight in-patient stays. The first of these will be for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the study will be conducted on an outpatient basis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2
Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias).
Time frame: 12 Weeks
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Placebo 1 tablet per day
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First Faculty of Medicine Charles University
Prague, Czechia
Dept. of Neurology - Second Faculty of Medicine Charles University
Prague, Czechia
Centre D'Investigation Clinique Pavillon Riser - Hopital Purpan
Toulouse, France
Parkinson's Competence Network Germany Dept. of Neurology - Philipps-University Marburg
Marburg, Hesse, Germany
Humboldt Universit?t Charite Neurologische Klinik
Berlin, Germany
Klinikum der Friedrich-Wilhelms- Univerit?t Bonn
Bonn, Germany
Zentralkrankenhaus Reinkenheide Neurologische Klinik
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...and 23 more locations