BCAAs in Concussion 3.0

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury, Concussion, Brain, Concussion

In brief

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.

Key facts

Study ID

NCT07670195

Run by

Akiva Cohen

People needed

150

Starts

2026-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-26

Who can join

Age: 11 and older, up to 23. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females,11 - 23 years of age.
• Weigh at least 40kg.
• 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.
• Present within 4 days of injury.
• Post-menarchal females must have a negative urine pregnancy test.
• Informed consent by the participant, or for participants <18 years old both informed consent by a parent/guardian and child assent.

You may not qualify if…

• Evidence of moderate or severe TBI, including 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.
• Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
• Non-English speaking participants or parent/guardian.

Full record on ClinicalTrials.gov

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