A Phase 2 interventional study of Biotin and Placebo Oral Tablet in Amyotrophic Lateral Sclerosis, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by American University of Beirut Medical Center · Phase 2, Interventional, and Treatment
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).
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →American University of Beirut Medical Center is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will received high dose of biotin (300 mg/day)
Drug: Biotin
Patients will receive placebo
Drug: Placebo Oral Tablet
High dose biotin
Also known as: vitamin B7
Placebo tablet similar in shape and size to the biotin tablet
Also known as: Placebo
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Any adverse effects resulting from receiving high dose biotin in patients with amyotrophic lateral sclerosis will be recorded
Time frame: 6 months
Motor disability measurement
The motor disability will be measured in the both arms using the revised amyotrophic lateral sclerosis functional rating scale (ALS-FRSr). This scale measures the progression and the severity of the disease. It is compose of 12 questions, each questions can have a score from 0 to 4. Questions 1 to 3 are related to bulbar onset, questions 4 to 9 are related to limb onset and questions 10-12 are related to respiratory onset. The minimum score is 0 and the maximum total score is 48. The higher the score the better the functional status. The lower the score the worse the functional status of the patient.
Time frame: 6 months
Change in Pulmonary function test parameters ( FEV1- FVC)
Forced expiratory volume in 1 second (FEV1) measured in percents and forced vital capacity (FVC) measured in liters will be measured in the both study arms.
Time frame: 6 months
Weight changes
Changes in body weight (in kilograms) will be measured in both study arms
Time frame: 6 months
Plan to share: Undecided
Ran from Jan 2018 to primary completion in May 2021, 39 months.
Of 37 non-industry phase 2 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 41. This study's 39 months is above that.
Counting every sponsor, half of 73 studies reached it within 24 months; a quarter within 16 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Biotin
Amyotrophic Lateral Sclerosis →
American University of Beirut Medical Center →