Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00403104
Last Updated: 2012-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2006-11-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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E
ONO-2506PO in the presence of Riluzole
ONO-2506PO
1200 mg QD / 18 months
P
Placebo in the presence of Riluzole
ONO-2506PO
0 mg QD / 18 months
Interventions
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ONO-2506PO
1200 mg QD / 18 months
ONO-2506PO
0 mg QD / 18 months
Eligibility Criteria
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Inclusion Criteria
2. Onset of muscle weakness within 14 months randomization
3. Concomitant standard Riluzole therapy (50mg twice daily)
Exclusion Criteria
2. Requirement for prescription drugs used for potential neuroprotective benefit -
18 Years
74 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Tomohiro Kuwayama
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
Vienna, , Austria
UCL Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille, , France
Hopital Duruytren
Limoges, , France
Hopital de la Timone
Marseille, , France
Hopital de Chauliac
Montpellier, , France
Hopital l-Archet 1
Nice, , France
Hopital LaPitie Salpetriere
Paris, , France
Charite Campus Virchow, ALS Ambulanz
Berlin, , Germany
Neurologische Universitatsklinik Bergmannsheil
Bochum, , Germany
Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
Erlangen, , Germany
Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
Halle, , Germany
Medizinische Hochschule Hannover, Neurologische Klinik
Hanover, , Germany
Interdisziplinares Zentrum fur Palliativmedizin
München, , Germany
Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
Ulm, , Germany
Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
Wiesbaden, , Germany
Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
Milan, , Italy
Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
Pavia, , Italy
Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
Torino, , Italy
Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
Amsterdam, , Netherlands
University Medial Center Utrecht
Utrecht, , Netherlands
Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
Sankt Gallen, , Switzerland
Academic Neuroscience Centre
London, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
University of Sheffield - Academic Neurology Unit
Sheffield, , United Kingdom
Countries
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Other Identifiers
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ONO-2506POE014
Identifier Type: -
Identifier Source: org_study_id
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