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RECRUITING Phase 2 ClinicalTrials.gov

BCAAs in Concussion 3.0

Sponsor: Akiva Cohen • ClinicalTrials.gov ID: NCT07670195

Registry updated: 2026-09-03
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Description

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.

Interventions

  • BCAA (Drug)
    The three BCAAs will be combined together into a powder formulation.
  • Placebo (Other)
    The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.

Eligibility criteria

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.

Conditions

Concussion (Diagnosis) MTBI - Mild Traumatic Brain Injury Concussion, Brain Concussion

Locations

  • Children's Hospital of Philadelphia — Havertown, Pennsylvania, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record