Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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