BCAAs in Concussion 2.0

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Annually, approximately 2 million concussions occur in the pediatric and young adult population. Approximately 30% of those diagnosed with concussion will experience persisting symptoms lasting beyond 28 days. Concussion is a heterogeneous injury to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no targeted therapeutics that can mitigate or prevent the deleterious effects of concussion. In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain amino acids (BCAAs) (valine, isoleucine, and leucine) were significantly reduced after injury. When these brain-injured animals received dietary supplementation with BCAAs, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. The pilot study (NCT01860404) provides evidence of BCAAs in concussed adolescents and young adults providing a dose-response effect in reducing concussion symptoms and a return to baseline physical activity in those treated with higher total doses of BCAAs, warranting this larger trial to inform clinical practice around BCAA treatment in concussion.

Conditions

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Concussion, Brain Concussion, Mild Concussion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Drug: Branched Chain Amino Acids

The three BCAAs will be combined together and dissolved into a flavored solution.

Group Type EXPERIMENTAL

BCAA

Intervention Type DRUG

The three BCAAs will be combined together and dissolved in a flavored solution.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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BCAA

The three BCAAs will be combined together and dissolved in a flavored solution.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Males and females,11 - 23 years of age.
2. Weigh at least 40kg.
3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
4. Present within 4 days of injury.
5. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria

1. Evidence of moderate or severe Traumatic Brain Injury (TBI), including Glasgow Coma Scale (GCS) \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
2. Prior concussion or TBI within 90 days.
3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
4. Any investigational drug use within 30 days prior to enrollment.
5. Hypersensitivity to any ingredient in the active or placebo products.
6. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
7. Non-English speaking participants or parent/guardian.

Minimum Eligible Age

11 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No