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
Inclusion Criteria12
- Male or female subject at least 18 years of age
- Subject can provide Informed Consent
- Concussion occurring in the course of AFL match play and
- diagnosed by a registered medical practitioner
- Able to initiate infusion of AST-004 within 6 h of concussion
- injury.
- Ability to complete study assessments including
- neuropsychological testing without accommodation
- Male and female participants of childbearing potential must
- agree to use an effective method of birth control during the
- study duration, or abstain from sexual relations that could
- result in pregnancy.
Exclusion Criteria28
- Participating in an interventional clinical study that may
- affect the results of this study (an observational study
- acceptable)
- Subject has had a documented concussion in the previous 6
- months
- Time of concussion injury cannot be accurately determined
- Females breastfeeding/lactating or with a positive urine
- pregnancy test.
- Known history of end-stage renal disease or receiving
- dialysis of any form
- Known history of seizures including febrile seizures or a first
- degree relative with epilepsy
- Venipuncture not feasible
- Diagnosis of migraine headaches as per a medical care
- provider and which requires prescription medication for
- treatment.
- Known or suspected history of other pre-existing medical,
- neurological, or psychiatric disease or clinically significant
- laboratory finding that in the principal investigator opinion
- would confound the neurological or functional evaluations of
- this study.
- Alcohol abuse disorder/dependence or participant is under
- the influence (test positive) of any alcohol, stimulant,
- nitrates, mind altering illicit drugs that would preclude
- immediate or completion of study assessments
- Administration within the past 90 days of darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide.
- Concussed player that requires a transfer to an emergency
- department
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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)
View Full Details on ANZCTR
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ACTRN12625000657426