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The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
This is an extension study which consists of two phases:
Double-blind phase; Patients will continue to take blinded study medication, as allocated in study ONO-2506POE014 by the central randomization system, in the presence of stable standard Riluzole therapy, until un-blinding of the study results.
Open label phase; Patients who were allocated to ONO-2506PO in the ONO-2506POE014 study will be offered entry into the open label phase of ONO-2506POE015 study and will continue to take 1200 mg of ONO-2506PO for the duration of their participation in the study, in the presence of stable standard Riluzole therapy. Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E | Experimental | ONO-2506PO in the presence of Riluzole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-2506PO | Drug | 1200mg QD / 5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Oct 2013 | |
| Death | Oct 2013 | |
| Tracheotomy or permanent assisted ventilation | Oct 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomohiro Kuwayama | Ono Pharma UK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Maloteaux, UCL Saint-Luc | Brussels | Belgium | ||||
| Prof. Wim Robberecht, UZ Leuven |
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| Leuven |
| Belgium |
| Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A | Lille | France |
| Prof. Philippe Couratier, Hopital Duruytren | Limoges | France |
| Prof. Jan Pouget, Hopital de la Timone | Marseille | France |
| Prof. William Camu, Hopital de Chauliac | Montpellier | France |
| Prof. Claude Desnuelle, Hopital 1-Archet 1 | Nice | France |
| Prof. Vincent Meininger, Hopital LaPitie Salpetriere | Paris | France |
| Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz | Berlin | Germany |
| Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil | Bochum | Germany |
| Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik | Erlangen | Germany |
| Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie | Halle | Germany |
| Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik | Hanover | Germany |
| Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin | München | Germany |
| Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm | Ulm | Germany |
| Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie | Wiesbarden | Germany |
| Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano | Milan | Italy |
| Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS | Pavia | Italy |
| Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette | Torino | Italy |
| Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology | Amsterdam | Netherlands |
| Prof. Leonard H Van Den Berg, University Medical Center Utrecht | Utrecht | Netherlands |
| Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic | Sankt Gallen | Switzerland |
| Prof. Nigel Leigh, Academic Neuroscience Centre | London | United Kingdom |
| Prof. Douglas Mitchell, Royal Preston Hospital | Preston | United Kingdom |
| Dr. Chris McDermott, Royal Hallamshire Hospital | 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 |
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