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

Amyotrophic Lateral Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306590
• Other study ID #: LIPCAL-ALS
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Dietary Supplement:
• Calogen

• Placebo

Locations

Country	Name	City	State
Germany	Department of Neurology, Humboldt University	Berlin
Germany	Neurologische Universitätsklinik Bergmannsheil	Bochum
Germany	Department of Neurology, TU Dresden	Dresden	Sachsen
Germany	Department of Neurology, University of Halle-Wittenberg	Halle/Saale	Sachsen-Anhalt
Germany	Department of Neurology, Medical School Hannover	Hannover	Niedersachsen
Germany	Department of Neurology, University of Jena	Jena	Thueringen
Germany	Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster	Münster
Germany	Department of Neurology, University of Rostock	Rostock	Mecklenburg-Vorpommern
Germany	Department of Neurology, University of Ulm	Ulm	Baden-Württemberg
Germany	Department of Neurology, DKD HELIOS Klinik	Wiesbaden
Germany	Department of Neurology, University of Wuerzburg	Wuerzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in ALS-patients with study intervention compared to placebo		18 months
Secondary	Change of total ALS functional rating scale revised (ALSFRS-R)		18 months
Secondary	Change of individual quality of life (SEIQoL)		18 months
Secondary	Change of the slow vital capacity (sVC)		18 months
Secondary	Time to tracheostomy or death (combined)		18 months
Secondary	Change of Body Mass Index (BMI)		18 months
Secondary	Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)		18 months