Back to resultsEfficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Calogen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival
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.
Sites / Locations
- Department of Neurology, University of Ulm
- Department of Neurology, University of Wuerzburg
- Department of Neurology, University of Rostock
- Department of Neurology, Medical School Hannover
- Department of Neurology, University of Halle-Wittenberg
- Department of Neurology, TU Dresden
- Department of Neurology, University of Jena
- Department of Neurology, Humboldt University
- Neurologische Universitätsklinik Bergmannsheil
- Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
- Department of Neurology, DKD HELIOS Klinik
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study Intervention
Placebo
Arm Description
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
Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
Outcomes
Primary Outcome Measures
Survival in ALS-patients with study intervention compared to placebo
Secondary Outcome Measures
Change of total ALS functional rating scale revised (ALSFRS-R)
Change of individual quality of life (SEIQoL)
Change of the slow vital capacity (sVC)
Time to tracheostomy or death (combined)
Change of Body Mass Index (BMI)
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02306590
Brief Title
Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
207 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Calogen
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Survival in ALS-patients with study intervention compared to placebo
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change of total ALS functional rating scale revised (ALSFRS-R)
Time Frame
18 months
Title
Change of individual quality of life (SEIQoL)
Time Frame
18 months
Title
Change of the slow vital capacity (sVC)
Time Frame
18 months
Title
Time to tracheostomy or death (combined)
Time Frame
18 months
Title
Change of Body Mass Index (BMI)
Time Frame
18 months
Title
Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert C. Ludolph, MD, Prof.
Organizational Affiliation
University Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, University of Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Department of Neurology, University of Wuerzburg
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Department of Neurology, University of Rostock
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
D-18147
Country
Germany
Facility Name
Department of Neurology, Medical School Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Department of Neurology, University of Halle-Wittenberg
City
Halle/Saale
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06097
Country
Germany
Facility Name
Department of Neurology, TU Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
D-01307
Country
Germany
Facility Name
Department of Neurology, University of Jena
City
Jena
State/Province
Thueringen
ZIP/Postal Code
D-07747
Country
Germany
Facility Name
Department of Neurology, Humboldt University
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Neurologische Universitätsklinik Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Department für Neurologie - Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Department of Neurology, DKD HELIOS Klinik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34433481
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.
Results Reference
derived
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Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
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