NCT03427086 is a Phase 2 clinical trial of Biotin in Amyotrophic Lateral Sclerosis, sponsored by American University of Beirut Medical Center.

Who is sponsoring NCT03427086?

NCT03427086 is sponsored by American University of Beirut Medical Center.

What drugs are being tested in NCT03427086?

Interventions in NCT03427086: Biotin, Placebo Oral Tablet.

What condition does NCT03427086 study?

NCT03427086 studies Amyotrophic Lateral Sclerosis.

Is NCT03427086 still recruiting?

NCT03427086 is currently completed. Last updated 1 September 2021.

Last reviewed 2021-09-01 · How we verify

NCT03427086

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 1 September 2021

What this trial tests

Phase 2 trial testing Biotin in Amyotrophic Lateral Sclerosis in 12 participants. Completed in 10 May 2021.

Timeline

29 January 2018

Primary endpoint
10 May 2021

10 May 2021

Quick facts

Lead sponsor	American University of Beirut Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	29 January 2018
Primary completion	10 May 2021
Estimated completion	10 May 2021
Sites	1 location across Lebanon

Drugs / interventions tested

Biotin (BIOTIN) — full drug profile →
Placebo Oral Tablet — full drug profile →

Conditions studied

Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

American University of Beirut Medical Center

Who can join

Adults 18 to 80, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Alpha-Lipoic Acid and Biotin in Neurodegenerative Diseases: Convergent Mechanistic Insights from Preclinical Models to Clinical Perspectives.
Aguilera-Méndez A, Aguilera-Manuel K, Saavedra-Molina A, Ríos-Chávez P, et al · · 2026 · PMID 42042751 · DOI 10.3390/neurolint18040064

Verify or expand the search:

Other trials of Biotin

Trials testing the same drug.

NCT03995277 — Effect of Biotin on Routine Laboratory Values · Phase 4 · completed
NCT03746821 — Biotin Sample Collection Study · NA · completed

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

NCT07502677 — Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Scle · recruiting
NCT07478172 — Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease · NA · recruiting
NCT07204977 — Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS) · Phase 1 · active not recruiting
NCT07290062 — A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants · Phase 1 · recruiting
NCT07259980 — A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD- · recruiting

Other American University of Beirut Medical Center trials

Trials by the same sponsor.

NCT07387848 — Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lym · Phase 2 · not yet recruiting
NCT07111000 — Testing the Epley Maneuver for Treating Dizziness in the Emergency Department: A Randomized Study · NA · not yet recruiting
NCT07059624 — Femoral Arterial Cannulation in Pediatrics · NA · recruiting
NCT06777875 — COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children · recruiting
NCT06815952 — Enhancing Difficult Laryngoscopy Prediction Through A Mixed Scoring System · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03427086 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by American University of Beirut Medical Center
Last refreshed: 1 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03427086.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing