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..
Astrocyte Pharmaceuticals Pty Ltd
60 participants
May 31, 2025
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
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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 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)
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ACTRN12625000657426