Clinical Research Directory

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.