CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Branched Chain Amino Acids +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01860404
NCT01860404Phase 2Completed

Head Injury Treatment With Healthy and Advanced Dietary Supplements (HIT HEADS): A Randomized, Placebo-controlled, Double-blinded, Therapeutic Exploratory Clinical Trial of Branched Chain Amino Acids (BCAA's) in the Treatment of Concussion

Children's Hospital of Philadelphia·interventional·Posted May 22, 2013·Updated May 14, 2024

In Brief

A Phase 2 clinical trial evaluating Branched Chain Amino Acids and Placebo solution for Brain Concussion. Completed, enrolled 42 participants across 1 site.

Detailed Summary

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAA's) in the treatment of concussion. The aim of the study is to determine whether, compared to placebo treatment, administration of BCAA's, at one or more doses, after a concussion improves neurocognitive recovery at one or more time-periods post concussion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 22, 2013
Enrollment StartJan 1, 2014
Primary CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 13.1 years ago

Interventions

Branched Chain Amino Acidsdrug

The three BCAA's will be combined together and dissolved in a flavored solution.

Placebo solutiondrug

The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.