Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- Drug: ONO-2506PO
- Registration Number
- NCT00403104
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
- Onset of muscle weakness within 14 months randomization
- Concomitant standard Riluzole therapy (50mg twice daily)
- Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- Requirement for prescription drugs used for potential neuroprotective benefit -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E ONO-2506PO ONO-2506PO in the presence of Riluzole P ONO-2506PO Placebo in the presence of Riluzole
- Primary Outcome Measures
Name Time Method Rate of decline of respiratory function determined as SVC over the 12 month treatment period 12 months
- Secondary Outcome Measures
Name Time Method Survival 12, 18 months Functional Assessment (ALSFRS-R) 12, 18 months Muscle Strength (MRC muscle score) 12, 18 months Quality of Life 12, 18 months
Trial Locations
- Locations (26)
UCL Saint-Luc
🇧🇪Brussels, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Hopital de la Timone
🇫🇷Marseille, France
Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
🇨ðŸ‡St. Gallen, Switzerland
Academic Neuroscience Centre
🇬🇧London, United Kingdom
Hopital Duruytren
🇫🇷Limoges Cedex, France
L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
🇦🇹Wien, Austria
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
🇫🇷Lille Cedex, France
Hopital de Chauliac
🇫🇷Montpellier cedex 5, France
Hopital l-Archet 1
🇫🇷Nice cedex 3, France
Hopital LaPitie Salpetriere
🇫🇷Paris, France
Charite Campus Virchow, ALS Ambulanz
🇩🇪Berlin, Germany
Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
🇩🇪Halle, Germany
Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
🇩🇪Erlangen, Germany
Neurologische Universitatsklinik Bergmannsheil
🇩🇪Bochum, Germany
Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
🇩🇪Wiesbaden, Germany
Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm
🇩🇪Ulm, Germany
Medizinische Hochschule Hannover, Neurologische Klinik
🇩🇪Hannover, Germany
Interdisziplinares Zentrum fur Palliativmedizin
🇩🇪Munchen, Germany
Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
🇮🇹Torino, Italy
Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
🇮🇹Milano, Italy
Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
🇳🇱Amsterdam, Netherlands
Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
🇮🇹Pavia, Italy
University Medial Center Utrecht
🇳🇱Utrecht, Netherlands
Royal Preston Hospital
🇬🇧Preston, United Kingdom
University of Sheffield - Academic Neurology Unit
🇬🇧Sheffield, United Kingdom