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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02306590
• Date of registration: 01/12/2014
• Prospective Registration: Yes
• Primary sponsor: University of Ulm
• Public title: Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis
• Date of first enrolment: February 2015
• Target sample size: 207
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02306590
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Albert C. Ludolph, MD, Prof.
• Affiliation: University Ulm

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Dietary Supplement: Calogen

Dietary Supplement: Placebo

Primary Outcome(s)

Survival in ALS-patients with study intervention compared to placebo [Time Frame: 18 months]

Secondary Outcome(s)

Time to tracheostomy or death (combined) [Time Frame: 18 months]

Change of the slow vital capacity (sVC) [Time Frame: 18 months]

Change of individual quality of life (SEIQoL) [Time Frame: 18 months]

Change of Appetite-Score, Council of Nutrition appetite questionnaire (CNAQ) [Time Frame: 18 months]

Change of total ALS functional rating scale revised (ALSFRS-R) [Time Frame: 18 months]

Change of Body Mass Index (BMI) [Time Frame: 18 months]

Secondary ID(s)

LIPCAL-ALS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors