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

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