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| Sponsored by: |
Ono Pharma |
|---|---|
| Information provided by: | Ono Pharma |
| ClinicalTrials.gov Identifier: | NCT00694941 |
Purpose
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis (ALS) |
Drug: ONO-2506PO |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | A Phase II Multi-Centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS) |
| Enrollment: | 15 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
E: Experimental
ONO-2506PO in the presence of Riluzole
|
Drug: ONO-2506PO
1200mg QD / 5 years
|
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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Belgium | |
| Prof. Wim Robberecht, UZ Leuven | |
| Leuven, Belgium | |
| Prof. Maloteaux, UCL Saint-Luc | |
| Brussels, Belgium | |
| France | |
| Prof. Vincent Meininger, Hopital LaPitie Salpetriere | |
| Paris, France | |
| Prof. Jan Pouget, Hopital de la Timone | |
| Marseille, France | |
| Prof. William Camu, Hopital de Chauliac | |
| Montpellier cedex 5, France | |
| Prof. Claude Desnuelle, Hopital 1-Archet 1 | |
| Nice cedex 3, France | |
| Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A | |
| Lille Cedex, France | |
| Prof. Philippe Couratier, Hopital Duruytren | |
| Limoges Cedex, France | |
| Germany | |
| Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik | |
| Erlangen, Germany | |
| Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie | |
| Wiesbarden, Germany | |
| Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz | |
| Berlin, Germany | |
| Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm | |
| Ulm, 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 | |
| Hannover, Germany | |
| Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil | |
| Bochum, Germany | |
| Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin | |
| Munchen, Germany | |
| Italy | |
| Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette | |
| Torino, Italy | |
| Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS | |
| Pavia, Italy | |
| Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano | |
| Milano, Italy | |
| Netherlands | |
| Prof. Leonard H Van Den Berg, University Medical Center Utrecht | |
| Utrecht, Netherlands | |
| Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology | |
| Amsterdam, Netherlands | |
| Switzerland | |
| Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic | |
| St. Gallen, Switzerland | |
| United Kingdom | |
| Prof. Douglas Mitchell, Royal Preston Hospital | |
| Preston, United Kingdom | |
| Prof. Nigel Leigh, Academic Neuroscience Centre | |
| London, United Kingdom | |
| Dr. Chris McDermott, Royal Hallamshire Hospital | |
| Sheffield, United Kingdom | |
| Study Director: | Tomohiro Kuwayama | Ono Pharma UK |
More Information
| Responsible Party: | Development Headquarters, ONO Pharmaceutical Co., Ltd ( Hiroshi Awata, Executive Director ) |
| Study ID Numbers: | ONO-2506POE015 |
| Study First Received: | June 6, 2008 |
| Last Updated: | December 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00694941 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Switzerland: Swissmedic; Italy: Ethics Committee |
|
ONO-2506PO Amyotrophic Lateral Sclerosis ALS |
|
Amyotrophic lateral sclerosis Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Central Nervous System Diseases Lou Gehrig's disease |
Sclerosis Degenerative motor system disease Neurodegenerative Diseases Motor neuron disease Motor Neuron Disease |
|
Pathologic Processes Nervous System Diseases |
