Status:
COMPLETED
Safety and Tolerability of High Dose Biotin in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
American University of Beirut Medical Center
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03427086
Start Date
January 29 2018
End Date
May 10 2021
Last Update
September 1 2021
Active Locations (1)
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1
American univeristy of Beirut medical center
Beirut, Lebanon, 1107 2020