Clinical trial NCT02306590: Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
survival time
ALS Functional Rating Scale
quality of life
survival
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Survival in ALS-patients with study intervention compared to placebo
timeFrame: 18 months
Secondary outcomes:
measure: Change of total ALS functional rating scale revised (ALSFRS-R)
timeFrame: 18 months
measure: Change of individual quality of life (SEIQoL)
timeFrame: 18 months
measure: Change of the slow vital capacity (sVC)
timeFrame: 18 months
measure: Time to tracheostomy or death (combined)
timeFrame: 18 months
measure: Change of Body Mass Index (BMI)
timeFrame: 18 months
measure: Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
timeFrame: 18 months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Neurology, University of Ulm
state: Baden-Württemberg
city: Wuerzburg
country: Germany
facility: Department of Neurology, University of Wuerzburg
state: Bayern
city: Rostock
country: Germany
facility: Department of Neurology, University of Rostock
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Department of Neurology, Medical School Hannover
state: Niedersachsen
city: Halle/Saale
country: Germany
facility: Department of Neurology, University of Halle-Wittenberg
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Department of Neurology, TU Dresden
state: Sachsen
city: Jena
country: Germany
facility: Department of Neurology, University of Jena
state: Thueringen
city: Berlin
country: Germany
facility: Department of Neurology, Humboldt University
city: Bochum
country: Germany
facility: Neurologische Universitätsklinik Bergmannsheil
city: Münster
country: Germany
facility: Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
city: Wiesbaden
country: Germany
facility: Department of Neurology, DKD HELIOS Klinik
Study officials:
affiliation: University Ulm
name: Albert C. Ludolph, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.