Status:
COMPLETED
Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
Lead Sponsor:
University of Ulm
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
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. Thi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT02306590
Start Date
February 1 2015
End Date
September 1 2018
Last Update
February 26 2019
Active Locations (11)
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1
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
2
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, Germany, 91054
3
Department of Neurology, Medical School Hannover
Hanover, Lower Saxony, Germany, 30625
4
Department of Neurology, University of Rostock
Rostock, Mecklenburg-Vorpommern, Germany, D-18147