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Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis

American University of Beirut Medical Center · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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amyotrophic-lateral-sclerosis
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).
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