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

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

Sponsors

Lead Sponsor: American University of Beirut Medical Center

Source American University of Beirut Medical Center
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 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).

Overall Status Recruiting
Start Date 2018-01-29
Completion Date 2021-01-10
Primary Completion Date 2021-01-10
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 6 months
Secondary Outcome
Measure Time Frame
Motor disability measurement 6 months
Change in Pulmonary function test parameters ( FEV1- FVC) 6 months
Weight changes 6 months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Biotin

Description: High dose biotin

Arm Group Label: Interventional

Intervention Type: Drug

Intervention Name: Placebo Oral Tablet

Description: Placebo tablet similar in shape and size to the biotin tablet

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Johnny Salameh, MD

Phone: 961-1-350000

Phone Ext.: 7550-7589

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: American univeristy of Beirut medical center Johnny Salameh, MD 961-1-350000 7550-7589 [email protected] Achraf Makki, MD, MSc Sub-Investigator
Location Countries

Lebanon

Verification Date

2020-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: American University of Beirut Medical Center

Investigator Full Name: Johnny Salameh

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Interventional

Type: Active Comparator

Description: Patient will received high dose of biotin (300 mg/day)

Label: Placebo

Type: Placebo Comparator

Description: Patients will receive placebo

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Prospective, double blind, placebo control, randomized 2:1 study

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: The subjects, care givers, investigator, and coordinator will be blinded. The pharmacist, who will be responsible for the drug supply, will be unblinded. The investigational drug and the placebo will have identical pill shape and color. They will be supplied in identical boxes.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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