The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00286897
- Lead Sponsor
- Eisai Limited
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 702
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (105)
C.H.U.de Charleroi
🇧🇪Charleroi, Belgium
Hopital St-Pierre
🇧🇪Ottignies, Belgium
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czech Republic
VFN Praha
🇨🇿Praha 2, Czech Republic
Tartu University Hospital
🇪🇪Tartu, Estonia
Kaunas Medical University Hospital
🇱🇹Kaunas, Lithuania
University Clinic Innsbruck
🇦🇹Innsbruck, Austria
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Clinic of Neurology and Psychiatry
🇷🇸Belgrade, Serbia and Montenegro, Serbia
University Hospital
🇨🇿Ostrava, Czech Republic
Servico de Neurologia
🇵🇹Coimbra, Portugal
Clinic of Neurology
🇷🇸Belgrade, Serbia and Montenegro, Serbia
Institute of Neurology
🇷🇸Belgrade, Serbia and Montenegro, Serbia
Klinik fuer Neurologie
🇩🇪Marburg, Germany
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Universita degli Studi Federico II
🇮🇹Napoli, Italy
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Department of Neurology
🇦🇹Vienna, Austria
Cliniques Universitaires St-Luc
🇧🇪Brussels, Belgium
Uzsoki Street Hospital
🇭🇺Budapest, Hungary
Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck
🇩🇪Lubeck, Germany
Clinexpert SMO, Budapest
🇭🇺Budapest, Hungary
Ospedale Civile di Pescara
🇮🇹Pescara, Italy
Vilnius University Hospital, Santariskiu Clinic
🇱🇹Vilnius, Lithuania
Centralny Szpital Kliniczny
🇵🇱Katowice, Poland
Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur
🇵🇱Mosina k/Poznania, Poland
WSS im. Kardynala S. Wyszynskiego
🇵🇱Lublin, Poland
Centrum Leczenia Chorob
🇵🇱Warszawa, Poland
Umhlanga Hospital
🇿🇦Umhlanga, South Africa
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
University College Hospital
🇬🇧London, United Kingdom
St Gorans Sjukhus
🇸🇪Stockholm, Sweden
Hospital de sant Pau
🇪🇸Barcelona, Spain
Royal Free Hospital
🇬🇧London, United Kingdom
North Manchester General Hospital
🇬🇧Crumpsall, United Kingdom
Hospital del Mar, Servei de Neurologia
🇪🇸Barcelona, Spain
North Surrey Primary Care Trust
🇬🇧Chertsey, United Kingdom
Hospital Clinico Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Universitatkrankenhaus Hamburg Eppendorf
🇩🇪Hamburg, Germany
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Nyiro Gyula Hospital
🇭🇺Gyor, Hungary
Nemocnice Pisek
🇨🇿Plsek, Czech Republic
St-Andries Ziekenhuis
🇧🇪Tielt, Belgium
Pliklinika Modry Pavilon
🇨🇿Ostrava 10, Czech Republic
FN Plzen
🇨🇿Plzen, Czech Republic
Nemocnice Pardubice
🇨🇿Pardubice, Czech Republic
Service Neurologie
🇫🇷Bayonne Cedex, France
CHU Gabrief Montpied
🇫🇷Clermont Ferrand, France
Parnu Hospital
🇪🇪Parnu, Estonia
Centre Hospitalier du Pays d'Aix
🇫🇷Aix-en-Provence, France
Paracelsus-Elena-Klinik
🇩🇪Kassel, Germany
Centre de Pharmacologie Clinique et Evaluation Therapeutique
🇫🇷Marseille Cedex 05, France
Kliniken Beelitz GmbH
🇩🇪Beelitz-Heilstatten, Germany
Contis, Patrick
🇫🇷Colomiers, France
Centre d'Investigation Clinique, Hospital Purpan
🇫🇷Toulouse Cedex 9, France
Hopital de la Pitie Salpetriere
🇫🇷Paris Cedex 13, France
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Neurologische Universitatsklinik
🇩🇪Gottingen, Germany
Gertrudis-Klinik, Parkinson Klinik
🇩🇪Leun-Biskirchen, Germany
Uni-klinikum Charite, Campus Virchow-klinikum
🇩🇪Berlin, Germany
Technische Universitaet Muenchen
🇩🇪Muenchen, Germany
LMU Munchen, Neurologische Universitatsklinik
🇩🇪Munchen, Germany
St. Imre Hospital
🇭🇺Budapest, Hungary
Semmelweis University
🇭🇺Budapest, Hungary
B-A-Z County Hospital
🇭🇺Budapest, Hungary
Jahn Ferenc Hospital
🇭🇺Budapest, Hungary
A Petz Hospital
🇭🇺Gyor, Hungary
Jahn Ferenc Del-Pesti Hospital
🇭🇺Miscolc, Hungary
Ichilov Sourasky MC
🇮🇱Petach-Tikva, Israel
Cham Sheba Medical Center
🇮🇱Haifa, Israel
Rambam Healthcare Center
🇮🇱Ramat-Gan, Israel
Rabin MC
🇮🇱Petach-Tikva, Israel
Carmel Medical Center
🇮🇱Tel Aviv, Israel
Assaf Harofe Medical Center
🇮🇱Zerafin, Israel
Ospedal Villa Margherita
🇮🇹Arcugnano, Italy
Universita degli Studi di Genova
🇮🇹Genova, Italy
Ospedale della Misericordia
🇮🇹Grosseto, Italy
IRCSS Fondazione Casimiro Mondino
🇮🇹Pavia, Italy
Policlinico Umberto I
🇮🇹Grosseto, Italy
Ospedale Versillia
🇮🇹Lido di Camaiore, Italy
Ospedale San Giovanni Battista
🇮🇹Roma, Italy
Nzoz Kendrion
🇵🇱Bialystok, Poland
Vilnius University Emergency Hospital
🇱🇹Vilnius, Lithuania
PSK Klinika Neurologii
🇵🇱Bialystok, Poland
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Hospital Santo Antonio
🇵🇹Porto, Portugal
Rosepark Hospital
🇿🇦Bloemfontein 9301, South Africa
407 Medi Clinic
🇿🇦Bloemfontein, South Africa
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Panorama Medi-Clinic
🇿🇦Parow, South Africa
Christian Barnard Memorial Hospital
🇿🇦Cape Town, South Africa
Wilgers Medical Centre
🇿🇦Pretoria, South Africa
406 Claremont Hospital
🇿🇦Cape Town, South Africa
Sunninghill Hospital
🇿🇦Sunninghill, Johannesburg, South Africa
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Bupa Flyde Coast Hospital
🇬🇧Blackpool, United Kingdom
Praktiken Ankaret
🇸🇪Karlstad, Sweden
District General Hospital NHS Trust
🇬🇧Clwyd, United Kingdom
Klinika Neurologii Doroslych AM
🇵🇱Gdansk, Poland
Specjalistyczna Przychodnia Lekarska
🇵🇱Plock, Poland
Centralny Szpital Kliniczny MSwia
🇵🇱Warszawa, Poland
U.Z. Antwerpen
🇧🇪Edegem, Belgium
U.Z. Gent
🇧🇪Gent, Belgium
C.H.R. de la Citadelle
🇧🇪Liege, Belgium