Status:
RECRUITING
Efficacy and Tolerability of Beta Hydroxybutyrate Ester in Patients With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
University of Ulm
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). One potential mechanism of weight loss in ALS is a disturbance of the mitochondrial complex I which causes an ...
Eligibility Criteria
Inclusion
- Probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
- loss of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis), based on the formula: (48 - score at screening visit) / (months between onset and screening visit)
- age ≥ 18 years
- continuously treated with 100 mg riluzole per day for at least 4 weeks
- capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)
Exclusion
- hyperinsulinism
- pyruvate decarboxylase deficit
- disturbance of fatty acid oxidation
- disturbance of gluconeogenesis
- acute porphyria
- metabolism disorders which prevent utilization or degradation of ketone bodies
- severe gastro-esophageal reflux
- renal insufficiency (medical history and/or elevated serum creatinine levels and/or glomerular filtration rate (GFR) \<90 ml/min
- previous participation in another interventional study within the preceding 4 weeks
- tracheostomy
- pregnancy or breast-feeding females
- evidence of a major psychiatric disorder or clinically evident dementia
- intake of diuretics
- severe dysphagia
- nutrition via percutaneous endoscopic gastrostomy (PEG)
- electrolyte or acid-base imbalance
- heart failure New York Heart Association (NYHA) II or above
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04820478
Start Date
April 1 2022
End Date
October 1 2025
Last Update
May 8 2024
Active Locations (1)
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1
University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081