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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental |
| |
| Experimental 2 | Experimental |
| |
| Experimental 3 | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug | Experimental 1 Drug: E2007 0.5 mg 1 tablet per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias). | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Webster | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Neurology, Faculty Hospital Olomouc | Olomouc | 775 20 | Czechia | |||
| Private Neurology Practise |
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| E2007 |
| Drug |
Experimental 2 Drug: E2007 1.0 mg 1 tablet per day |
|
| E2007 | Drug | Drug: E2007 2.0 mg 1 tablet per day |
|
| Placebo Comparator | Other | Placebo 1 tablet per day |
|
| Ostrava |
| 702 00 |
| Czechia |
| Department of Neurology, Regional Hospital Pardubice | Pardubice | 532 03 | Czechia |
| First Faculty of Medicine Charles University | Prague | 120 00 | Czechia |
| Dept. of Neurology - Second Faculty of Medicine Charles University | Prague | 84 - 150 06 | Czechia |
| Centre D'Investigation Clinique Pavillon Riser - Hopital Purpan | Toulouse | 31059 | France |
| Parkinson's Competence Network Germany Dept. of Neurology - Philipps-University Marburg | Marburg | Hesse | 35039 | Germany |
| Humboldt Universit?t Charite Neurologische Klinik | Berlin | D-13353 | Germany |
| Klinikum der Friedrich-Wilhelms- Univerit?t Bonn | Bonn | D-53105 | Germany |
| Zentralkrankenhaus Reinkenheide Neurologische Klinik | Bremerhaven | D-27574 | Germany |
| Klinikum der Heinrich-Heine- Universit?t | D?sseldorf | D-40225 | Germany |
| Praxis | Erbach im Odenwald | D-64711 | Germany |
| Klinikum der Georg-August- Universit?t | G?ttingen | D-37099 | Germany |
| Universit?tskrankenh aus Hamburg Eppendorf | Hamburg | D-20246 | Germany |
| Krankenhaus Hanau | Hanau | D-63450 | Germany |
| Medizinische Hochschule Hannover | Hanover | D-30623 | Germany |
| Universit?tsklinikum Heidelberg | Heidelberg | D-69120 | Germany |
| Universit?tsklinikum | Homburg/Saar | D-66421 | Germany |
| Paracelsus-Elena-Kli nik | Kassel | D-34126 | Germany |
| Hopital Roger Salengro | Lille | 59037 | Germany |
| Universit?tsklinikum Rostock Klinik f?r Neurologie | Rostock | D-18147 | Germany |
| Reparto di Neurologia - Ospedale Misericordia | Grosseto | 171 - 58100 | Italy |
| Universit? di Napoli Federico II | Naples | 5 - 80131 | Italy |
| Unit? Operativa Parkinson e Disordini del Movimento | Pavia | 6 - 27100 | Italy |
| Istituto Neuromed SRL Neurologia | Pozzilli | 18 - 86077 | Italy |
| III Clinica Neurologica | Roma | 30 - 00185 | Italy |
| Militzary Medical Academy | Belgrade | 11000 | Serbia |
| Clinic of Neurology | Belgrade | Serbia |
| Institute of Neurology | Belrade | Serbia |
| Hospital Vall d'Hebron | Barcelona | 119 - 08035 | Spain |
| Hospital del Mar | Barcelona | 25-29 08003 | Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona | 8036 | Spain |
| Hospital Mutua de Terrassa | Terrassa | 25-27 - 08221 | Spain |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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