Status:
COMPLETED
BCAA Supplementation for Concussion
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
The Dana Foundation
Main Line Health
Conditions:
Brain Concussion
Eligibility:
All Genders
11-34 years
Phase:
PHASE2
Brief Summary
This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to...
Detailed Description
Annually, between 100,000 to 140,000 children present to the emergency department for concussion in the United States.1 The Centers for Disease Control now estimates that 1.6 - 3.8 million sports rela...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and females, ages 11 - 34 years, of any race.
- Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment.
- Ability to have daily email and internet access.
- Females must have a negative urine pregnancy test and must use an acceptable method of contraception.
- Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent.
- Informed consent by the subject, or for subjects \<18 years old both informed consent by a parent/guardian and child assent.
- Exclusion Criteria
- Witnessed seizure at the time of injury or penetrating head injury.
- Prior concussion or TBI within 90 days.
- Concussion or TBI severe enough to require admission to an intensive care unit for observation or intervention.
- Previous history of TBI or concussion requiring admission to the hospital, disabling stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.
- Subjects taking neurological or psychoactive medications as a regular daily prescription medication.
- 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.
- Allergy to Food, Drug, and Cosmetic (FD\&C) Red #40 (red dye 40) or Sucralose.
- Lactating females.
- Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01860404
Start Date
January 1 2014
End Date
January 1 2023
Last Update
May 14 2024
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104