Phase 2
N=42
BCAA Supplementation for Concussion
Brain Concussion
Bottom Line
View on ClinicalTrials.gov: NCT01860404 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Reaction Time Difference Between Drug and Placebo Groups — 2.44; 2.49; 2.52; 2.48 log(milliseconds) — p=0.871
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Branched Chain Amino Acids (Drug); Placebo solution (Drug)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaction Time Difference Between Drug and Placebo Groups |
2.44; 2.49; 2.52; 2.48; 2.48 | 0.871 |
| SECONDARY Clinical Symptoms |
3; 2; 0; 0; 0 | 0.140 |
| SECONDARY Return to Physical Activity Baseline |
2; 1.5; 3; 3; 5 | 0.267 |
| SECONDARY Neurocognitive Recovery-- Attention |
2.65; 2.60; 2.73; 2.74; 2.69 | 0.476 |
| SECONDARY Compliance and Adherence to Treatment |
81; 64.3; 54.8; 23.8; 49.0 | 0.581 |
| SECONDARY Tolerability of BCAA's Based on Adverse Events |
3; 3; 1; 0; 1 | 0.203 |
| SECONDARY Safety and BCAA Supplementation |
0; 0; 0; 0; 0 | 1.00 |
| SECONDARY Neurocognitive Recovery-- Working Memory |
2.69; 2.70; 2.84; 2.82; 2.74 | 0.482 |
| SECONDARY Neurocognitive Recovery-- Visual Memory |
1.24; 1.11; 0.99; 0.75; 1.05 | 0.393 |
| SECONDARY Return to Baseline Cognitive Activity |
2; 3; 4; 4; 3 | 0.629 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01860404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.