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

Study Overview
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Brief Summary
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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
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Dietary Supplement: Calogen
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Intervention<br>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<br> <br> |
| Placebo Comparator: Placebo<br>Placebo drinking solution 8 kcal/90ml/day in addition to daily food intake and standard of care | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in ALS-patients with study intervention compared to placebo |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival