NCT03427086

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Biotin	High dose biotin
DRUG	Placebo Oral Tablet	Placebo tablet similar in shape and size to the biotin tablet

Timeline

• Start date: 2018-01-29
• Primary completion: 2021-05-10
• Completion: 2021-05-10
• First posted: 2018-02-09
• Last updated: 2021-09-01

Locations

1 site across 1 country: Lebanon