Kurzfassung

This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind study comparing placebo with a high caloric fat emulsion 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. After patients are screened for inclusion and exclusion criteria, they will be randomly...This is a prospective, multicenter, randomized, stratified, parallel-group, double-blind study comparing placebo with a high caloric fat emulsion 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. After patients are screened for inclusion and exclusion criteria, they will be randomly assigned to treatment with either placebo or dietary supplement (405 kcal) according to their stratum (bulbar onset vs. spinal onset; low BMI vs. high BMI). Patients will be treated for 18 months in this study. The study requires an initial screening visit (V1), 3 subsequent control visits (V2-V4), and three telephone contacts (T1-T3).
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