RECRUITINGPhase 2INTERVENTIONAL
BCAAs in Concussion 2.0
HIT HEADS 2.0: Head Injury Treatment: A Randomized, Placebo-controlled, Double-blinded, Therapeutic Clinical Trial of Branched Chain Amino Acids (BCAAs) in the Treatment of Concussion
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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. willing to sign a consent form by the participant, or for participants \<18 years old both willing to sign a consent form by a parent/guardian and child assent.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
BCAA
The three BCAAs will be combined together and dissolved in a flavored solution.
OTHER
Placebo
The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
Locations (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States