BCAAs in Concussion 3.0
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age11-23
SponsorAkiva Cohen
About this trial
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
Qualifiers
Males and females,11 - 23 years of age.
Weigh at least 40kg.
Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
Present within 4 days of injury.
Disqualifiers
Evidence of moderate or severe TBI, including GCS <13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
Prior concussion or TBI within 90 days.
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.
Trial design
Treatments tested in this trial
- BCAA
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Akiva Cohen
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Source ClinicalTrials.gov