BCAAs in Concussion 2.0 (NCT06829498) | Clinical Trial Compass
Active — Not RecruitingPhase 2
BCAAs in Concussion 2.0
United States17 participantsStarted 2025-04-01
Plain-language summary
This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.
Who can participate
Age range
11 Years – 23 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females,11 - 23 years of age.
. Weigh at least 40kg.
. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
. Present within 4 days of injury.
. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants that have met have met criteria for recovery at 28 days post-injury, defined as return to baseline symptom levels along with feeling > 90% back to normal.
. Evidence of moderate or severe Traumatic Brain Injury (TBI), including Glasgow Coma Scale (GCS) \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
. Prior concussion or TBI within 90 days.
. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
. Any investigational drug use within 30 days prior to enrollment.
. Hypersensitivity to any ingredient in the active or placebo products.
. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
. Non-English speaking participants or parent/guardian.