Ultra-high-caloric, Fatty Diet in ALS

Korábbi kezelés

• Previous participation in another interventional study involving an active treatment within the preceding 4 weeks
• Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.

Más betegség

• Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
• Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.

Egyéb

• Tracheostomy or continuous permanent ventilator dependence (>22 hours per day)
• Pregnancy or breastfeeding
• 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

• Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria
• Disease duration (onset of first paresis or bulbar symptoms) < 24 months
• Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit)
• Age ≥18 years.
• Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion
• Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion
• Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion
• Capable of thoroughly understanding all information given
• full written informed consent according to good clinical practice