Amyotrophic Lateral Sclerosis
Conditions
Keywords
amyotrophic lateral sclerosis, survival time, ALS Functional Rating Scale, quality of life, survival
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.
Interventions
DIETARY_SUPPLEMENTCalogen
DIETARY_SUPPLEMENTPlacebo
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival in ALS-patients with study intervention compared to placebo | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Change of individual quality of life (SEIQoL) | 18 months |
| Change of the slow vital capacity (sVC) | 18 months |
| Change of total ALS functional rating scale revised (ALSFRS-R) | 18 months |
| Change of Body Mass Index (BMI) | 18 months |
| Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) | 18 months |
| Time to tracheostomy or death (combined) | 18 months |
Countries
Germany
Outcome results
None listed