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

NCT02306590 | Completed DMC

• 1 other identifier: LIPCAL-ALS
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 11

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; survival time; ALS Functional Rating Scale; quality of life; survival

Outcome Measures

Primary Outcomes (1)

• Survival in ALS-patients with study intervention compared to placebo

  18 months

Secondary Outcomes (6)

• Change of total ALS functional rating scale revised (ALSFRS-R)

  18 months

• Change of individual quality of life (SEIQoL)

  18 months

• Change of the slow vital capacity (sVC)

  18 months

• Time to tracheostomy or death (combined)

  18 months

• Change of Body Mass Index (BMI)

  18 months

Study Arms (2)

Study Intervention

EXPERIMENTAL

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

Dietary Supplement: Calogen

Placebo

PLACEBO COMPARATOR

Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care

Dietary Supplement: Placebo

Interventions

Calogen DIETARY_SUPPLEMENT

Study Intervention

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (11)

Department of Neurology, University of Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Department of Neurology, University of Wuerzburg

Würzburg, Bavaria, 91054, Germany

Location

Department of Neurology, Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Department of Neurology, University of Rostock

Rostock, Mecklenburg-Vorpommern, D-18147, Germany

Location

Department of Neurology, TU Dresden

Dresden, Saxony, D-01307, Germany

Location

Department of Neurology, University of Halle-Wittenberg

Halle, Saxony-Anhalt, 06097, Germany

Location

Department of Neurology, University of Jena

Jena, Thuringia, D-07747, Germany

Location

Department of Neurology, Humboldt University

Berlin, 13353, Germany

Location

Neurologische Universitätsklinik Bergmannsheil

Bochum, 44789, Germany

Location

Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster

Münster, 48149, Germany

Location

Department of Neurology, DKD HELIOS Klinik

Wiesbaden, 65191, Germany

Location

Related Publications (1)

• Witzel S, Frauhammer F, Steinacker P, Devos D, Pradat PF, Meininger V, Halbgebauer S, Oeckl P, Schuster J, Anders S, Dorst J, Otto M, Ludolph AC. Neurofilament light and heterogeneity of disease progression in amyotrophic lateral sclerosis: development and validation of a prediction model to improve interventional trials. Transl Neurodegener. 2021 Aug 26;10(1):31. doi: 10.1186/s40035-021-00257-y.

  PMID: 34433481 DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Albert C. Ludolph, MD, Prof.

  University Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departement of Neurology

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

DE (11)