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.
Further study details as provided by University of Ulm:
Primary Outcome Measures:
Survival in ALS-patients with study intervention compared to placebo [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Change of total ALS functional rating scale revised (ALSFRS-R) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change of individual quality of life (SEIQoL) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change of the slow vital capacity (sVC) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Time to tracheostomy or death (combined) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change of Body Mass Index (BMI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
18 years or older; both genders; no healthy volunteers; possible, probable (clinically or laboratory supported) or definite ALS; Continuously treated with 100 mg riluzole daily for minimum 4 weeks