BCAA Supplementation for Concussion

NCT01860404 | Completed Phase 2 Results

• 1 other identifier: 13-010227
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Concussion

Keywords

Concussion; Branched chain amino acids; BCAA; HIT HEADS

Outcome Measures

Primary Outcomes (1)

• Reaction Time Difference Between Drug and Placebo Groups

  Processing speed subtest of the Axon Sports Computerized Cognitive Assessment Tool. The values provided are the median of log reaction time to the processing speed subtest, where a lower score indicates a faster time and thus improved processing speed.

  Day 21

Secondary Outcomes (9)

• Clinical Symptoms

  Day 21

• Return to Physical Activity Baseline

  Day 21

• Neurocognitive Recovery-- Attention

  Day 21

• Compliance and Adherence to Treatment

  Day 21

• Tolerability of BCAA's Based on Adverse Events

  Day 21

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo will be administered orally twice daily for 21 days

Drug: Placebo solution

Branched Chain Amino Acids (27g BID)

EXPERIMENTAL

27 grams of BCAA's will be administered twice-daily for 21 days

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (22.5g BID)

EXPERIMENTAL

22.5 grams of BCAA's will be administered twice-daily for 21 days

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (15g BID)

EXPERIMENTAL

15 grams of BCAA's will be administered twice-daily for 21 days

Drug: Branched Chain Amino Acids

Branched Chain Amino Acids (7.5g BID)

EXPERIMENTAL

7.5 grams of BCAA's will be administered twice-daily for 21 days

Drug: Branched Chain Amino Acids

Interventions

Branched Chain Amino Acids DRUG

The three BCAA's will be combined together and dissolved in a flavored solution.

Branched Chain Amino Acids (15g BID); Branched Chain Amino Acids (22.5g BID); Branched Chain Amino Acids (27g BID); Branched Chain Amino Acids (7.5g BID)

Placebo solution DRUG

The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.

Placebo

Eligibility Criteria

• Age: 11 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• The Dana Foundation: collaborator
• Main Line Health: collaborator
• University of Pennsylvania: collaborator
• Pennsylvania Department of Health: collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Cole JT, Mitala CM, Kundu S, Verma A, Elkind JA, Nissim I, Cohen AS. Dietary branched chain amino acids ameliorate injury-induced cognitive impairment. Proc Natl Acad Sci U S A. 2010 Jan 5;107(1):366-71. doi: 10.1073/pnas.0910280107. Epub 2009 Dec 7.

  PMID: 19995960 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Limitations and Caveats

There are several key limitations to our study that necessitate a larger, more definitive trial. Due to a combination of initially more strict inclusion criteria, and the impact of the coronavirus pandemic, our sample size was smaller than anticipated. This, combined with poorer than expected follow-up, led us to have to use alternative statistical analytic methods. We were further limited by missing data. This also necessitated the alternative analytic approach / post-hoc analysis.

Results Point of Contact

• Title: Dr. Daniel Corwin
• Organization: Children's Hospital of Philadelphia

corwind@chop.edu

215-327-2306

Study Officials

• Sage Myers, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Locations

US (1)