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

• ClinicalTrials.gov Identifier: NCT02306590
• Recruitment Status: Completed
• First Posted: December 3, 2014
• Last Update Posted: February 26, 2019
• Sponsor: University of Ulm
• Information provided by (Responsible Party): Albert Christian Ludolph, Prof., University of Ulm

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis	Dietary Supplement: Calogen; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 207 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: February 2015
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Dietary Supplement: Calogen
Placebo Comparator: Placebo; Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care	Dietary Supplement: Placebo

Outcome Measures

Primary Outcome Measures :

1. Survival in ALS-patients with study intervention compared to placebo [ Time Frame: 18 months ]

Secondary Outcome Measures :

1. Change of total ALS functional rating scale revised (ALSFRS-R) [ Time Frame: 18 months ]
2. Change of individual quality of life (SEIQoL) [ Time Frame: 18 months ]
3. Change of the slow vital capacity (sVC) [ Time Frame: 18 months ]
4. Time to tracheostomy or death (combined) [ Time Frame: 18 months ]
5. Change of Body Mass Index (BMI) [ Time Frame: 18 months ]
6. Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) [ Time Frame: 18 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Department of Neurology, University of Ulm

Ulm, Baden-Württemberg, Germany, 89081

Department of Neurology, University of Wuerzburg

Wuerzburg, Bayern, Germany, 91054

Department of Neurology, University of Rostock

Rostock, Mecklenburg-Vorpommern, Germany, D-18147

Department of Neurology, Medical School Hannover

Hannover, Niedersachsen, Germany, 30625

Department of Neurology, University of Halle-Wittenberg

Halle/Saale, Sachsen-Anhalt, Germany, 06097

Department of Neurology, TU Dresden

Dresden, Sachsen, Germany, D-01307

Department of Neurology, University of Jena

Jena, Thueringen, Germany, D-07747

Department of Neurology, Humboldt University

Berlin, Germany, 13353

Neurologische Universitätsklinik Bergmannsheil

Bochum, Germany, 44789

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

Münster, Germany, 48149

Department of Neurology, DKD HELIOS Klinik

Wiesbaden, Germany, 65191

Sponsors and Collaborators

University of Ulm

Investigators

• Principal Investigator: Albert C. Ludolph, MD, Prof.; University Ulm

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Albert Christian Ludolph, Prof., Departement of Neurology, University of Ulm
• ClinicalTrials.gov Identifier: NCT02306590
• Other Study ID Numbers: LIPCAL-ALS
• First Posted: December 3, 2014
• Last Update Posted: February 26, 2019
• Last Verified: February 2019

Keywords provided by Albert Christian Ludolph, Prof., University of Ulm:

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

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases