Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental | ONO-2506PO in the presence of Riluzole |
|
| P | Placebo Comparator | Placebo in the presence of Riluzole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2506PO | Drug | 1200 mg QD / 18 months |
| |
| ONO-2506PO |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline of respiratory function determined as SVC over the 12 month treatment period | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 12, 18 months | |
| Functional Assessment (ALSFRS-R) | 12, 18 months | |
| Muscle Strength (MRC muscle score) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tomohiro Kuwayama | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien | Vienna | 1100 | Austria | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
0 mg QD / 18 months |
|
| 12, 18 months |
| Quality of Life | 12, 18 months |
| UCL Saint-Luc |
| Brussels |
| Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Hopital Roger Salengro - Clinique Neurologique, Neurologie A | Lille | 59037 | France |
| Hopital Duruytren | Limoges | 87042 | France |
| Hopital de la Timone | Marseille | 13005 | France |
| Hopital de Chauliac | Montpellier | 34295 | France |
| Hopital l-Archet 1 | Nice | 06202 | France |
| Hopital LaPitie Salpetriere | Paris | 75013 | France |
| Charite Campus Virchow, ALS Ambulanz | Berlin | 13353 | Germany |
| Neurologische Universitatsklinik Bergmannsheil | Bochum | 44789 | Germany |
| Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik | Erlangen | 91054 | Germany |
| Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie | Halle | 06120 | Germany |
| Medizinische Hochschule Hannover, Neurologische Klinik | Hanover | 30623 | Germany |
| Interdisziplinares Zentrum fur Palliativmedizin | München | Germany |
| Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| Deutsche Klinik fur Diagnostik, Fachbereich Neurologie | Wiesbaden | 65191 | Germany |
| Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano | Milan | 20149 | Italy |
| Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS | Pavia | 27100 | Italy |
| Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette | Torino | 10126 | 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 | 9007 | Switzerland |
| Academic Neuroscience Centre | London | United Kingdom |
| Royal Preston Hospital | Preston | PR29HT | United Kingdom |
| University of Sheffield - Academic Neurology Unit | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided