A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Interventions
- Drug: ONO-2506PO
- Registration Number
- NCT00694941
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
- Detailed Description
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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Adult male and female patients with diagnosis of ALS over the age of 18 years.
- Previous randomization and completion of the last visits in ONO-2506POE014 study.
- Patients whom the investigator has no concern and judges tolerable for the continued treatment with ONO-2506PO and Riluzole from a risk and benefit point of view.
- A clinically relevant medical history or presence of cardiovascular, gastrointestinal, renal, hepatic, endocrine/metabolic, neurologic, lymphatic, haematologic, immunologic, musculoskeletal, connective tissue, dermatologic, genito/urinary, psychiatric diseases or disorders that, in the opinion of the investigator may pose an unwarranted risk to the patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E ONO-2506PO ONO-2506PO in the presence of Riluzole
- Primary Outcome Measures
Name Time Method Adverse Events Oct 2013 Death Oct 2013 Tracheotomy or permanent assisted ventilation Oct 2013
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Prof. Nigel Leigh, Academic Neuroscience Centre
🇬🇧London, United Kingdom
Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
🇳🇱Amsterdam, Netherlands
Dr. Chris McDermott, Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
🇩🇪Hannover, Germany
Prof. Maloteaux, UCL Saint-Luc
🇧🇪Brussels, Belgium
Prof. Wim Robberecht, UZ Leuven
🇧🇪Leuven, Belgium
Prof. Philippe Couratier, Hopital Duruytren
🇫🇷Limoges Cedex, France
Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
🇫🇷Lille Cedex, France
Prof. Jan Pouget, Hopital de la Timone
🇫🇷Marseille, France
Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
🇩🇪Erlangen, Germany
Prof. William Camu, Hopital de Chauliac
🇫🇷Montpellier cedex 5, France
Prof. Claude Desnuelle, Hopital 1-Archet 1
🇫🇷Nice cedex 3, France
Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
🇩🇪Wiesbarden, Germany
Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
🇩🇪Halle, Germany
Prof. Vincent Meininger, Hopital LaPitie Salpetriere
🇫🇷Paris, France
Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
🇩🇪Berlin, Germany
Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
🇮🇹Milano, Italy
Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
🇩🇪Munchen, Germany
Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
🇩🇪Ulm, Germany
Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
🇮🇹Pavia, Italy
Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
🇨ðŸ‡St. Gallen, Switzerland
Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
🇮🇹Torino, Italy
Prof. Douglas Mitchell, Royal Preston Hospital
🇬🇧Preston, United Kingdom
Prof. Leonard H Van Den Berg, University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
🇩🇪Bochum, Germany