RecruitingPhase 2ACTRN12625000657426

STARFAST: Study of Traumatic Brain Injury (TBI)/ Concussions in Australian-Rules Footballers receiving AST-004.

A Phase 2 Double-Blinded Placebo-Controlled Study of the Safety and Clinical Efficacy signals of AST-004 infusion for Traumatic Brain Injury (TBI)/Concussions in Australian-Rules Footballers..


Sponsor

Astrocyte Pharmaceuticals Pty Ltd

Enrollment

60 participants

Start Date

May 31, 2025

Study Type

Interventional

Conditions

Summary

The study aims to evaluate the safety and efficacy signals of AST 004 as an acute intervention in athletes who sustain a sports related concussion during match play on game day. Adverse events, blood protein biomarker improvement, and clinical improvement will be analysed and neuropsychological testing assessed.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Concussion in contact sport is a serious and common injury, and current management is largely focused on rest and gradual return to play. This study is testing a new drug called AST-004 as an immediate treatment given to AFL footballers within six hours of sustaining a concussion during a match. The treatment is delivered as an intravenous infusion (a drip), and researchers will track whether it reduces blood markers of brain injury, speeds up clinical recovery, and is safe. The study also includes neuropsychological testing — memory and cognitive assessments — to measure whether brain function recovers more quickly with the treatment. This study is open to AFL players aged 18 and over who have been diagnosed with a concussion during a match by a registered medical practitioner and can receive treatment within six hours. Players who have had a concussion in the past six months, have a history of seizures, kidney disease, or migraine requiring prescription medication are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

AST-004 will be infused as Low Dose: 100 mg loading dose infused over 10 minutes followed by 80 mg/hr for 6 hours or High Dose: 130 mg loading dose infused over 10 minutes followed by 180 mg/hr for 6

AST-004 will be infused as Low Dose: 100 mg loading dose infused over 10 minutes followed by 80 mg/hr for 6 hours or High Dose: 130 mg loading dose infused over 10 minutes followed by 180 mg/hr for 6 hours. In order to maintain the blind, players who are randomized to placebo will be at the high dose or low dose infusion rate. Placebo will contain only commercially available normal saline. Enrolled participants will only receive 1 dose of AST-004 or Placebo in the clinical trial


Locations(1)

SA, Australia

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