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Amino Acid Supplement

Branched Chain Amino Acids for Concussion (HIT_HEADS Trial)

Phase 2
Waitlist Available
Led By Sage Myers, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 21

Summary

This trial is testing if taking extra BCAA's can help children and others recover better from concussions. BCAA's are nutrients that might fix brain damage by restoring important amino acids. The goal is to see if this helps improve thinking and behavior after a concussion.

Eligible Conditions
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reaction Time Difference Between Drug and Placebo Groups
Secondary study objectives
Clinical Symptoms
Compliance and Adherence to Treatment
Neurocognitive Recovery-- Attention
+6 more

Side effects data

From 2023 Phase 2 trial • 42 Patients • NCT01860404
38%
Mild (not interfering with daily life) or Moderate (limitation to daily activity)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Branched Chain Amino Acids (7.5g BID)
Branched Chain Amino Acids (15g BID)
Branched Chain Amino Acids (22.5g BID)
Branched Chain Amino Acids (27g BID)

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Branched Chain Amino Acids (7.5g BID)Experimental Treatment1 Intervention
7.5 grams of BCAA's will be administered twice-daily for 21 days
Group II: Branched Chain Amino Acids (27g BID)Experimental Treatment1 Intervention
27 grams of BCAA's will be administered twice-daily for 21 days
Group III: Branched Chain Amino Acids (22.5g BID)Experimental Treatment1 Intervention
22.5 grams of BCAA's will be administered twice-daily for 21 days
Group IV: Branched Chain Amino Acids (15g BID)Experimental Treatment1 Intervention
15 grams of BCAA's will be administered twice-daily for 21 days
Group V: PlaceboPlacebo Group1 Intervention
Placebo will be administered orally twice daily for 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Branched Chain Amino Acids
2019
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
729 Previous Clinical Trials
8,470,230 Total Patients Enrolled
The Dana FoundationOTHER
17 Previous Clinical Trials
942 Total Patients Enrolled
Main Line HealthOTHER
21 Previous Clinical Trials
6,847 Total Patients Enrolled
~4 spots leftby Nov 2025
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