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

NCT ID: NCT02306590

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study Intervention

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

Group Type: EXPERIMENTAL

Calogen

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Calogen

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Albert Christian Ludolph, Prof.

Departement of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert C. Ludolph, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Ulm

Locations

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

Department of Neurology, DKD HELIOS Klinik

Wiesbaden, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34433481 (View on PubMed)

Other Identifiers

LIPCAL-ALS

Identifier Type: -

Identifier Source: org_study_id