- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00694941
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Patients who were allocated to placebo in ONO-2506POE014 study will be withdrawn from ONO-2506POE015 study, but will continue to be followed up by their site with standard care.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brussels, Belgium
- Prof. Maloteaux, UCL Saint-Luc
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Leuven, Belgium
- Prof. Wim Robberecht, UZ Leuven
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Lille Cedex, France
- Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
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Limoges Cedex, France
- Prof. Philippe Couratier, Hopital Duruytren
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Marseille, France
- Prof. Jan Pouget, Hopital de la Timone
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Montpellier cedex 5, France
- Prof. William Camu, Hopital de Chauliac
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Nice cedex 3, France
- Prof. Claude Desnuelle, Hopital 1-Archet 1
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Paris, France
- Prof. Vincent Meininger, Hopital LaPitie Salpetriere
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Berlin, Germany
- Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz
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Bochum, Germany
- Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil
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Erlangen, Germany
- Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik
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Halle, Germany
- Prof. Stephan Zierz, Martin Luther Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie
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Hannover, Germany
- Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik
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Munchen, Germany
- Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin
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Ulm, Germany
- Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm
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Wiesbarden, Germany
- Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie
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Milano, Italy
- Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano
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Pavia, Italy
- Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS
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Torino, Italy
- Prof. Adriano Chio, Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette
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Amsterdam, Netherlands
- Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology
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Utrecht, Netherlands
- Prof. Leonard H Van Den Berg, University Medical Center Utrecht
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St. Gallen, Switzerland
- Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic
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London, United Kingdom
- Prof. Nigel Leigh, Academic Neuroscience Centre
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Preston, United Kingdom
- Prof. Douglas Mitchell, Royal Preston Hospital
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Sheffield, United Kingdom
- Dr. Chris McDermott, Royal Hallamshire Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: E
ONO-2506PO in the presence of Riluzole
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1200mg QD / 5 years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse Events
Time Frame: Oct 2013
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Oct 2013
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Death
Time Frame: Oct 2013
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Oct 2013
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Tracheotomy or permanent assisted ventilation
Time Frame: Oct 2013
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Oct 2013
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tomohiro Kuwayama, Ono Pharma UK
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONO-2506POE015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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