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

Study Purpose:

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 Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Drug

Intervention Name:

Biotin, Placebo Oral Tablet

Placebo:

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

Achraf Makki, MD, American University of Beirut Medical Center, Johnny Salameh, MD, American University of Beirut Medical Center

Clinicaltrials.gov ID:

NCT03427086

Neals Affiliated?

Coordinating Center Contact Information

Study Sponsor:

American University of Beirut Medical Center

Estimated Enrollment:

Estimated Study Start Date:

01 / 29 / 2018

Estimated Study Completion Date:

05 / 10 / 2021

Posting Last Modified Date:

09 / 01 / 2021

Date Study Added to neals.org:

02 / 09 / 2018

Minimum Age:

18 Years

Maximum Age:

80 Years

Inclusion Criteria:

- Amyotrophic Lateral Sclerosis (ALS) volunteers must be diagnosed within 3 years prior to participation as having possible, probable, or definite ALS, either sporadic or familial according to modified El Escorial criteria

- Age 18-80, able to provide informed consent, and comply with study procedures

- Participants must not have started Riluzole and/or Nuedexta for at least 30 days, or be on a stable dose of Riluzole and/or Nuedexta for at least 30 days, prior to screening (Riluzole and/or Nuedexta -naïve participants are permitted in the study)

Exclusion Criteria:

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to PI judgment.

- Exposure to any experimental agent within 30 days of entry or at any time during the trial or enrollment in another research study within 30 days of or during this trial.

- Slow Vital Capacity test less than 50% of the predicted value Patients who had already undergone tracheostomy

American univeristy of Beirut medical center

Beirut 1107 2020
Lebanon