BCAAs in Concussion 2.0
HIT HEADS 2.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2025
CompletedFirst Posted
Study publicly available on registry
February 17, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
June 13, 2025
June 1, 2025
1.3 years
January 30, 2025
June 11, 2025
Conditions
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 (54g/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
- +8 more secondary outcomes
Study Arms (2)
Drug: Branched Chain Amino Acids
EXPERIMENTALThe three BCAAs will be combined together and dissolved into a flavored solution.
Placebo
PLACEBO COMPARATORThe placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
Interventions
Eligibility Criteria
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.
- Present within 4 days of injury.
- Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
- 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 Traumatic Brain Injury (TBI), including Glasgow Coma Scale (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.
- Hypersensitivity to any ingredient in the active or placebo products.
- Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
- Non-English speaking participants or parent/guardian.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akiva Cohenlead
Study Sites (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
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: 38468511BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Corwin, MD
Children's Hospital of Philadelphia
Central Study Contacts
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
January 30, 2025
First Posted
February 17, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share