Status:
COMPLETED
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the s...
Eligibility Criteria
Inclusion
- Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
- Onset of muscle weakness within 14 months randomization
- Concomitant standard Riluzole therapy (50mg twice daily)
Exclusion
- Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
- Requirement for prescription drugs used for potential neuroprotective benefit -
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00403104
Start Date
November 1 2006
End Date
December 1 2008
Last Update
June 13 2012
Active Locations (26)
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1
L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien
Vienna, Austria, 1100
2
UCL Saint-Luc
Brussels, Belgium
3
UZ Leuven
Leuven, Belgium, 3000
4
Hopital Roger Salengro - Clinique Neurologique, Neurologie A
Lille, France, 59037