A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
1 other identifier
interventional
15
7 countries
25
Brief Summary
The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 6, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedJune 13, 2012
June 1, 2012
6 months
June 6, 2008
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Events
Oct 2013
Death
Oct 2013
Tracheotomy or permanent assisted ventilation
Oct 2013
Study Arms (1)
E
EXPERIMENTALONO-2506PO in the presence of Riluzole
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Prof. Maloteaux, UCL Saint-Luc
Brussels, Belgium
Prof. Wim Robberecht, UZ Leuven
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomohiro Kuwayama
Ono Pharma UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2008
First Posted
June 11, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2008
Last Updated
June 13, 2012
Record last verified: 2012-06