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NCT07670195
BCAAs in Concussion 3.0
Conditions: Concussion (Diagnosis), MTBI - Mild Traumatic Brain Injury, Concussion, Brain, Concussion
Sex: All
Ages: 11 Years – 23 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 150
Sponsor: Akiva Cohen
Location: Children's Hospital of Philadelphia Havertown Pennsylvania
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 Criteria
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.
a. One or more clinical signs or two or more acute symptoms with at least one VVE abnormality.
4. Present within 4 days of injury.
5. Post-menarchal females must have a negative urine pregnancy test.
6. Informed consent by the participant, or for participants \
Source: ClinicalTrials.gov (NCT07670195). StuddyBuddy aggregates publicly available trial information.
