Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Calogen

• Registration Number: NCT02306590
• Lead Sponsor: University of Ulm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Study Start: 2015-02
• Primary Completion: 2018-01
• Study Completion: 2018-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
• Disease duration < 36 months
• Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
• Age ≥18 years
• Continuously treated with 100 mg riluzole daily for at least four weeks
• Capable of thoroughly understanding all information given and giving full informed consent according to GCP
• Willing to complete a diet questionnaire throughout participation in the study

Exclusion Criteria

• Simultaneous participation in another interventional clinical study
• Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
• Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
• Tracheostomy
• Patients with gastrostomy
• Pregnancy or breastfeeding
• Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
• Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.
• Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.
• Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
Study Intervention	Calogen	High caloric fatty diet for drinking (100% lipids, 4.5 kcal/ml) 405 kcal/90 ml/day in addition to daily food intake and standard of care; corresponding to an additional intake of 45 g fat per day

Primary Outcome Measures

Name	Time	Method
Survival in ALS-patients with study intervention compared to placebo	18 months

Secondary Outcome Measures

Name	Time	Method
Change of total ALS functional rating scale revised (ALSFRS-R)	18 months
Change of the slow vital capacity (sVC)	18 months
Change of individual quality of life (SEIQoL)	18 months
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)	18 months
Time to tracheostomy or death (combined)	18 months
Change of Body Mass Index (BMI)	18 months

Trial Locations

Locations (11)

Department of Neurology, DKD HELIOS Klinik; 🇩🇪 Wiesbaden, Germany

Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Department of Neurology, University of Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Department of Neurology, University of Rostock; 🇩🇪 Rostock, Mecklenburg-Vorpommern, Germany

Department of Neurology, University of Wuerzburg; 🇩🇪 Wuerzburg, Bayern, Germany

Department of Neurology, Medical School Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Department of Neurology, TU Dresden; 🇩🇪 Dresden, Sachsen, Germany

Department of Neurology, University of Halle-Wittenberg; 🇩🇪 Halle/Saale, Sachsen-Anhalt, Germany

Department of Neurology, University of Jena; 🇩🇪 Jena, Thueringen, Germany

Department of Neurology, Humboldt University; 🇩🇪 Berlin, Germany

Neurologische Universitätsklinik Bergmannsheil; 🇩🇪 Bochum, Germany