CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Biotin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03427086
NCT03427086Phase 2Completed
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Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis

American University of Beirut Medical Center·interventional·Posted Feb 9, 2018·Updated Sep 1, 2021

In Brief

A Phase 2 clinical trial evaluating Biotin and Placebo Oral Tablet for Amyotrophic Lateral Sclerosis. Completed, enrolled 12 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesLebanon
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartJan 29, 2018
Primary CompletionMay 10, 2021
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.4 years ago

Interventions

Biotindrug

High dose biotin

Placebo Oral Tabletdrug

Placebo tablet similar in shape and size to the biotin tablet