BCAAs in Concussion: a higher-dose test in teens and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 trial evaluating high-dose branched-chain amino acids (BCAAs) for concussion recovery in people aged 11 to 23 who recently sustained a concussion. Participants are assigned to receive either BCAAs or placebo and are followed to assess symptom resolution and return to activity. The study builds on prior smaller studies suggesting a dose-related improvement in concussion symptoms with BCAAs. It aims to determine safety, tolerability, and potential efficacy to support future clinical use. The trial is conducted at a single site, the Children’s Hospital of Philadelphia, under a lead sponsor, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males and females,11 - 23 years of age.
2. Weigh at least 40kg.
3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.

   a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality.
4. Present within 4 days of injury.
5. Post-menarchal females must have a negative urine pregnancy test.
6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria:

1. Evidence of moderate or severe TBI, including GCS \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
2. Prior concussion or TBI within 90 days.
3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
4. Any investigational drug use within 30 days prior to enrollment.
5. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
6. Non-English speaking participants or parent/guardian.

Where it's running

• Children's Hospital of Philadelphia
  Havertown, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Daniel Corwin, MD — Children's Hospital of Philadelphia
• Study coordinator: Olivia E. Podolak
• Email: podolako@chop.edu
• Phone: 8626687645

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.