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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004314-33 | EudraCT Number |
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Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias. |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Alessia Nicotra, MD, PhD, DIC | Eisai Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Innsbruck | Innsbruck | 6020 | Austria | |||
| Department of Neurology |
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| Vienna |
| Austria |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| C.H.U.de Charleroi | Charleroi | 6000 | Belgium |
| U.Z. Antwerpen | Edegem | 2650 | Belgium |
| U.Z. Gent | Ghent | 9000 | Belgium |
| C.H.R. de la Citadelle | Liège | 4000 | Belgium |
| Hopital St-Pierre | Ottignies | 1340 | Belgium |
| St-Andries Ziekenhuis | Tielt | 8700 | Belgium |
| University Hospital | Olomouc | 77520 | Czechia |
| University Hospital | Ostrava | 70852 | Czechia |
| Pliklinika Modry Pavilon | Ostrava | 71000 | Czechia |
| Nemocnice Pardubice | Pardubice | 53203 | Czechia |
| FN Plzen | Pilsen | 30460 | Czechia |
| Nemocnice Pisek | Plsek | 39723 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 10034 | Czechia |
| VFN Praha | Prague | 12800 | Czechia |
| Parnu Hospital | Pärnu | 80010 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| Centre Hospitalier du Pays d'Aix | Aix-en-Provence | 13090 | France |
| Service Neurologie | Bayonne | 64100 | France |
| CHU Gabrief Montpied | Clermont-Ferrand | 69003 | France |
| Contis, Patrick | Colomiers | 31770 | France |
| Lille | France |
| Centre de Pharmacologie Clinique et Evaluation Therapeutique | Marseille | 13385 | France |
| Nantes | France |
| Hopital de la Pitie Salpetriere | Paris | 75013 | France |
| Centre d'Investigation Clinique, Hospital Purpan | Toulouse | 31059 | France |
| Kliniken Beelitz GmbH | Beelitz-Heilstätten | Germany |
| Uni-klinikum Charite, Campus Virchow-klinikum | Berlin | 13353 | Germany |
| Bochum | Germany |
| Universitaetsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Neurologische Universitatsklinik | Göttingen | Germany |
| Universitatkrankenhaus Hamburg Eppendorf | Hamburg | D 20246 | Germany |
| Hanau | Germany |
| Hanover | Germany |
| Paracelsus-Elena-Klinik | Kassel | 34128 | Germany |
| Gertrudis-Klinik, Parkinson Klinik | Leun-Biskirchen | Germany |
| Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck | Lübeck | 23538 | Germany |
| Klinik fuer Neurologie | Marburg | 35033 | Germany |
| Technische Universitaet Muenchen | München | 81675 | Germany |
| LMU Munchen, Neurologische Universitatsklinik | München | Germany |
| Tübingen | Germany |
| Wiesbaden | 65191 | Germany |
| Clinexpert SMO, Budapest | Budapest | 1091 | Hungary |
| St. Imre Hospital | Budapest | 1115 | Hungary |
| Semmelweis University | Budapest | 1145 | Hungary |
| Uzsoki Street Hospital | Budapest | 1145 | Hungary |
| Jahn Ferenc Hospital | Budapest | 1204 | Hungary |
| B-A-Z County Hospital | Budapest | 3501 | Hungary |
| Budapest | Hungary |
| A Petz Hospital | Győr | 9024 | Hungary |
| Nyiro Gyula Hospital | Győr | Hungary |
| Jahn Ferenc Del-Pesti Hospital | Miscolc | 3501 | Hungary |
| Cham Sheba Medical Center | Haifa | 52621 | Israel |
| Rabin MC | Petah Tikva | 49372 | Israel |
| Ichilov Sourasky MC | Petah Tikva | 64239 | Israel |
| Rambam Healthcare Center | Ramat Gan | 52621 | Israel |
| Carmel Medical Center | Tel Aviv | Israel |
| Assaf Harofe Medical Center | Zerafin | 70300 | Israel |
| Ospedal Villa Margherita | Arcugnano | 36057 | Italy |
| Universita degli Studi di Genova | Genova | 16132 | Italy |
| Ospedale della Misericordia | Grosseto | 58100 | Italy |
| Policlinico Umberto I | Grosseto | 58100 | Italy |
| Ospedale Versillia | Lido di Camaiore | 55043 | Italy |
| Universita degli Studi Federico II | Naples | 80131 | Italy |
| IRCSS Fondazione Casimiro Mondino | Pavia | 27100 | Italy |
| Ospedale Civile di Pescara | Pescara | 65124 | Italy |
| Ospedale San Giovanni Battista | Roma | 00148 | Italy |
| Roma | Italy |
| Kaunas Medical University Hospital | Kaunas | LT5009 | Lithuania |
| Vilnius University Emergency Hospital | Vilnius | 04130 | Lithuania |
| Vilnius University Hospital, Santariskiu Clinic | Vilnius | 2600 | Lithuania |
| Nzoz Kendrion | Bialystok | 15420 | Poland |
| PSK Klinika Neurologii | Bialystok | Poland |
| Klinika Neurologii Doroslych AM | Gdansk | 80211 | Poland |
| Centralny Szpital Kliniczny | Katowice | 40752 | Poland |
| WSS im. Kardynala S. Wyszynskiego | Lublin | 20718 | Poland |
| Lublin | Poland |
| Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur | Mosina k/Poznania | 62050 | Poland |
| Specjalistyczna Przychodnia Lekarska | Płock | 09402 | Poland |
| Centralny Szpital Kliniczny MSwia | Warsaw | 02507 | Poland |
| Warsaw | 02507 | Poland |
| Centrum Leczenia Chorob | Warsaw | 02777 | Poland |
| Servico de Neurologia | Coimbra | 3000-075 | Portugal |
| Hospital Santa Maria | Lisbon | 1649-035 | Portugal |
| Hospital Santo Antonio | Porto | 4099-001 | Portugal |
| Clinic of Neurology and Psychiatry | Belgrade, Serbia and Montenegro | Serbia |
| Clinic of Neurology | Belgrade, Serbia and Montenegro | Serbia |
| Institute of Neurology | Belgrade, Serbia and Montenegro | Serbia |
| 407 Medi Clinic | Bloemfontein | 9301 | South Africa |
| Rosepark Hospital | Bloemfontein | South Africa |
| Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| Christian Barnard Memorial Hospital | Cape Town | 8001 | South Africa |
| 406 Claremont Hospital | Cape Town | South Africa |
| Morningside, Johannesburg | 2196 | South Africa |
| Panorama Medi-Clinic | Parow | 7550 | South Africa |
| Wilgers Medical Centre | Pretoria | 0041 | South Africa |
| Sunninghill Hospital | Sunninghill, Johannesburg | 2052 | South Africa |
| Umhlanga Hospital | Umhlanga | 4321 | South Africa |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital de sant Pau | Barcelona | 8025 | Spain |
| Hospital Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital del Mar, Servei de Neurologia | Barcelona | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Puerta de Hierro | Madrid | 28035 | Spain |
| Clinica Universitaria de Navarra | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Praktiken Ankaret | Karlstad | 65224 | Sweden |
| St Gorans Sjukhus | Stockholm | 11281 | Sweden |
| Bupa Flyde Coast Hospital | Blackpool | FY38BP | United Kingdom |
| North Surrey Primary Care Trust | Chertsey | KT160QA | United Kingdom |
| District General Hospital NHS Trust | Clwyd | LL185UJ | United Kingdom |
| North Manchester General Hospital | Crumpsall | M85RB | United Kingdom |
| Royal Free Hospital | London | NW32QG | United Kingdom |
| University College Hospital | London | W1N8AA | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S102FJ | United Kingdom |
| 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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