Trials / Completed
CompletedNCT00403104
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 420 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
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 slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-2506PO | 1200 mg QD / 18 months |
| DRUG | ONO-2506PO | 0 mg QD / 18 months |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2006-11-23
- Last updated
- 2012-06-13
Locations
26 sites across 8 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00403104. Inclusion in this directory is not an endorsement.