Status:
COMPLETED
A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00694941
Start Date
June 1 2008
Last Update
June 13 2012
Active Locations (25)
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1
Prof. Maloteaux, UCL Saint-Luc
Brussels, Belgium
2
Prof. Wim Robberecht, UZ Leuven
Leuven, Belgium
3
Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille, France
4
Prof. Philippe Couratier, Hopital Duruytren
Limoges, France