BCAA's in Concussion

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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 determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: Main Line Health; Pennsylvania Department of Health; The Dana Foundation; University of Pennsylvania
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria

1. Males and females, ages 11 - 34 years, of any race.

2. Subjects who had a concussion, as diagnosed by a qualified physician, within 72 hours prior to enrollment.

3. Ability to have daily email and internet access.

4. Females must have a negative urine pregnancy test and must use an acceptable method of contraception.

5. Subjects must, in the opinion of the referring physician, have the capacity to provide informed consent.

6. Informed consent by the subject, or for subjects <18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria

1. Witnessed seizure at the time of injury or penetrating head injury.

2. Prior concussion or TBI within 90 days.

3. Concussion or TBI severe enough to require admission to an intensive care unit for observation or intervention.

4. Previous history of TBI or concussion requiring admission to the hospital, disabling stroke, epilepsy, brain tumor, neurodegenerative condition, or psychiatric disease.

5. Subjects taking neurological or psychoactive medications as a regular daily prescription medication.

6. Known history of maple syrup urine disease or known family history of maple syrup urine disease.

7. Any investigational drug use within 30 days prior to enrollment.

8. Allergy to Food, Drug, and Cosmetic (FD&C) Red #40 (red dye 40) or Sucralose.

9. Lactating females.

10. Parents/guardians or subjects who, in the opinion of the investigators, may be non-compliant with study schedules or procedures.