Trials / Completed
CompletedNCT01879241
Study of Rasagiline in Patients With Amyotrophic Lateral Sclerosis
Efficacy, Safety and Tolerability Study of 1 mg Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) - An AMG Trial With a Market Authorized Substance
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- University of Ulm · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the trial is to investigate the survival time (the time from randomization until death or end of the trial) compared between control group and experimental group. This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with 1 mg/d rasagiline as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 250 enrolled patients. For entry, the El Escorial Criteria for the diagnosis of ALS will be used. The patients have to be stable on riluzole at least 4 weeks prior to randomization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rasagiline | |
| DRUG | Placebo | a sugar pill manufactured to mimic Rasagiline 1 mg tablet |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2016-04-01
- Completion
- 2016-08-01
- First posted
- 2013-06-17
- Last updated
- 2016-10-25
Locations
15 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01879241. Inclusion in this directory is not an endorsement.