Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis
Status:
Completed
Trial end date:
2021-05-10
Target enrollment:
Participant gender:
Summary
This is a randomized double blinded randomized 2:1 study. The duration of the study is 6
month. The safety and tolerability of high doses of biotin (300 mg/ day) will be compared to
placebo in patients with amyotrophic lateral sclerosis. Patients will be evaluated at
baseline, 3, and 6 month. The primary outcome will be any adverse effects recorded. The
secondary outcomes will be motor disability measured by ALS-FRS, change in Pulmonary function
test parameters (FEV1- FVC), change in subject weight (in kg).