The primary objective of the trial is to investigate the survival time (the time from randomization until death or date of end of the study) compared between control group and experimental group. This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind trial comparing placebo with high caloric fatty diet for drinking as add-on therapy to 100 mg riluzole in amyotrophic lateral sclerosis (ALS) in 200 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
DOUBLE
Enrollment
207
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, Germany
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, Germany
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Department of Neurology, TU Dresden
Dresden, Saxony, Germany
Department of Neurology, University of Halle-Wittenberg
Halle, Saxony-Anhalt, Germany
Department of Neurology, University of Jena
Jena, Thuringia, Germany
Department of Neurology, Humboldt University
Berlin, Germany
Neurologische Universitätsklinik Bergmannsheil
Bochum, Germany
Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
Münster, Germany
...and 1 more locations
Survival in ALS-patients with study intervention compared to placebo
Time frame: 18 months
Change of total ALS functional rating scale revised (ALSFRS-R)
Time frame: 18 months
Change of individual quality of life (SEIQoL)
Time frame: 18 months
Change of the slow vital capacity (sVC)
Time frame: 18 months
Time to tracheostomy or death (combined)
Time frame: 18 months
Change of Body Mass Index (BMI)
Time frame: 18 months
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.