Recruiting
Phase 2

BCAAs

Sponsor:

Akiva Cohen

Code:

NCT07670195

Conditions

Concussion (Diagnosis)

MTBI - Mild Traumatic Brain Injury

Concussion, Brain

Concussion

Eligibility Criteria

Sex: All

Age: 11 - 23

Healthy Volunteers: Accepted

Interventions

BCAA

Placebo

Study Details

Brief 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.

Conditions

Concussion (Diagnosis)

MTBI - Mild Traumatic Brain Injury

Concussion, Brain

Concussion

Study ID

NCT07670195

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 23

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Drug: Branched Chain Amino Acids

The three BCAAs will be combined together into a powder formulation.

placebo comparator: Placebo

The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.

Interventions

BCAA

The three BCAAs will be combined together into a powder formulation.

Placebo

The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.

Primary outcome measure

  • 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. [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Havertown, Pennsylvania, United States, 19083

Contacts

Principal Investigator:

Daniel Corwin, MD

More Information

Sponsor

Akiva Cohen

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • Concussion
  • mTBI
  • BCAAs
  • Branched Chain Amino Acids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Akiva Cohen on 2026-09-03.