Concussion Clinical Trials

Find Concussion Clinical Trials Near You

HIT HEADS 3.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 23
Healthy Volunteers: t
View:

• Males and females,11 - 23 years of age.

• Weigh at least 40kg.

• Meeting concussion criteria for the American Congress of Rehabilitative Medicine.

• a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality.

• Present within 4 days of injury.

• Post-menarchal females must have a negative urine pregnancy test.

• Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Havertown
Contact Information
Primary
Olivia E. Podolak
podolako@chop.edu
8626687645
Time Frame
Start Date: 2026-08-05
Estimated Completion Date: 2027-12
Participants
Target number of participants: 150
Treatments
Experimental: Drug: Branched Chain Amino Acids
The three BCAAs will be combined together into a powder formulation.
Placebo_comparator: Placebo
The placebo formulation will have similar taste, texture, consistency and appearance as the BCAA formulation.
Related Therapeutic Areas
Sponsors
Leads: Akiva Cohen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials