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Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis | Clinical Trials | Clareo Health

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

NCT02306590•University of Ulm

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (11)

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

Key Dates

Start Date

February 1, 2015

Primary Completion Date

January 1, 2018

Completion Date

September 1, 2018

Last Updated

February 26, 2019

Enrollment

207

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Calogen

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

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RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITING

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

UPenn Observational Research Repository on Neurodegenerative Disease

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Control Cohort CTRL COH

ASSESS ALL ALS Study