Actively Recruiting

Phase 2
Age: 11Years - 23Years
All Genders
NCT06829498

BCAAs in Concussion 2.0

Led by Akiva Cohen · Updated on 2025-06-13

150

Participants Needed

1

Research Sites

69 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

BCAAs in Concussion 2.0

Who Can Participate

Age: 11Years - 23Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 11 to 23 years
  • Weigh at least 40 kg
  • Meet concussion criteria set by the American Congress of Rehabilitative Medicine
  • Present for study within 4 days of concussion injury
  • Post-menarchal females must have a negative urine pregnancy test and use acceptable contraception
  • Provide informed consent; participants under 18 require parental consent and child assent
Not Eligible

You will not qualify if you...

  • Moderate or severe traumatic brain injury (GCS less than 13), hospital admission, or neurosurgical intervention
  • Prior concussion or traumatic brain injury within 90 days
  • Known personal or family history of maple syrup urine disease
  • Use of any investigational drug within 30 days prior to enrollment
  • Hypersensitivity to any ingredient in the study products
  • Pregnancy, planning pregnancy during study, or breastfeeding
  • Non-English speaking participants or parent/guardian

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19146

Actively Recruiting

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Research Team

O

Olivia Podolak

CONTACT

M

Melissa Godfrey, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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BCAAs in Concussion 2.0 | DecenTrialz