BCAAs in Concussion 3.0

NCT07670195 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-024503
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Keywords

Concussion; mTBI; BCAAs; Branched Chain Amino Acids

Outcome Measures

Primary Outcomes (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.

  This will be determined by research staff at in person visits by the return to baseline symptom levels along with participant self-report of feeling \> 90% back to normal. Percentage recovered at 28 days will be compared between placebo and control group by chi-square testing.

  28 days

Secondary Outcomes (13)

• Determine whether administration of high-dose BCAAs (30g/day) compared to placebo supplementation, promotes concussion recovery operationalized by the return to baseline (pre-injury) concussion symptom levels.

  28 days

• Determine whether administration of BCAAs leads to a lower visio-vestibular abnormality burden compared to placebo.

  28 days

• Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--maximum pupil diameter compared to placebo.

  28 days

• Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities--minimum pupil diameter compared to placebo.

  28 days

• Determine whether administration of BCAAs leads to improved pupillary light reflex (PLR) abnormalities-percentage of pupil constriction compared to placebo.

  28 days

Study Arms (2)

Drug: Branched Chain Amino Acids

EXPERIMENTAL

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

Drug: BCAA

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

BCAA DRUG

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

Drug: Branched Chain Amino Acids

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 11 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Akiva Cohen: lead

Related Publications (1)

• Corwin DJ, Myers SR, Arbogast KB, Lim MM, Elliott JE, Metzger KB, LeRoux P, Elkind J, Metheny H, Berg J, Pettijohn K, Master CL, Kirschen MP, Cohen AS. Head Injury Treatment With Healthy and Advanced Dietary Supplements: A Pilot Randomized Controlled Trial of the Tolerability, Safety, and Efficacy of Branched Chain Amino Acids in the Treatment of Concussion in Adolescents and Young Adults. J Neurotrauma. 2024 Jun;41(11-12):1299-1309. doi: 10.1089/neu.2023.0433. Epub 2024 Apr 11.

  PMID: 38468511 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Disease

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Corwin, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia E. Podolak

CONTACT

8626687645; podolako@chop.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share