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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
252
a sugar pill manufactured to mimic Rasagiline 1 mg tablet
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany
Department of Neurology, Technische Universität München
Munich, Bavaria, Germany
Survival in ALS-Patients with Rasagiline compared to placebo
Time frame: 18 Months
Change of total score of ALS Functional Rating Scale - Revised (ALSFRS-R)
Time frame: 18 Months
Change of individual Quality of Life (SEIQoL, Schedule for the Evaluation of Individual Quality of Life
Time frame: 18 Months
Change of slow vital capacity
Time frame: 18 Months
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Department of Neurology, Universty of Regensburg
Regensburg, Bavaria, Germany
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, Germany
Department of Neurology, Deutsche Klinik für Diagnostik
Wiesbaden, Hesse, Germany
Department of Neurology, University of Goettingen
Göttingen, Lower Saxony, Germany
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, Germany
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Department of Neurology, Universty of Bonn
Bonn, Nordrhrein-Westfalen, Germany
Neurologische Universitätsklinik Bergmannsheil
Bochum, North Rhine-Westphalia, Germany
...and 5 more locations