Clinical trial: Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis (NCT02306590)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment