Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000657426
Ethics application status
Approved
Date submitted
22/05/2025
Date registered
20/06/2025
Date last updated
20/06/2025
Date data sharing statement initially provided
20/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
STARFAST: Study of Traumatic Brain Injury (TBI)/ Concussions in Australian-Rules Footballers receiving AST-004.
Scientific title
A Phase 2 Double-Blinded Placebo-Controlled Study of the Safety of AST-004 infusion for Traumatic Brain Injury (TBI)/Concussions in Australian-Rules Footballers..
Secondary ID [1] 314511 0
AST-004-2-02
Universal Trial Number (UTN)
Trial acronym
STARFAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 337589 0
Condition category
Condition code
Neurological 333933 333933 0 0
Neurodegenerative diseases
Injuries and Accidents 334016 334016 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 331139 0
Treatment: Drugs
Comparator / control treatment
AST-004 will be infused as low dose or high dose over a 6hr period. 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.
Control group
Placebo

Outcomes
Primary outcome [1] 341822 0
To evaluate the safety of AST-004 as an intravenous infusion in athletes concussed during match play in Australian Rules Football.
Timepoint [1] 341822 0
Baseline, Pre-Dose, 3hrs, 6hrs, 15hrs, 20hrs, Day 2 and Day 7 post dose.
Secondary outcome [1] 447988 0
To evaluate the effect of AST-004 on blood brain biomarkers compared to baseline and across treatment groups.
Timepoint [1] 447988 0
Baseline, Pre-Dose, 3hrs, 6hrs, 15hrs 20hrs, Day 2 and Day 7, Day 14, Day 21 post dose.
Secondary outcome [2] 447989 0
Changes in Post Concussion Symptom Scale (PCSS) following administration of AST-004.
Timepoint [2] 447989 0
Baseline, Day 1, Day 2, Day 7, Day 14, Day 21, Day 30 post dose.
Secondary outcome [3] 448306 0
Changes in Vestibular/Ocular-Motor Screening (VOMS) following administration of AST-004.
Timepoint [3] 448306 0
Day 1, Day 2, Day 7, Day 14, Day 21, Day 30 post dose.
Secondary outcome [4] 448307 0
Changes in Trail-Making Test (TMT) Parts A and B following administration of AST-004. The TMT will be assessing visual attention, mental flexibility, processing speed, and motor speed.
Timepoint [4] 448307 0
Day 1, Day 2, Day 7, Day 14, Day 21, Day 30 post dose.

Eligibility
Key inclusion criteria
Inclusion Criteria:
1. Male or female subject at least 18 years of age
2. Subject can provide Informed Consent
3. Concussion occurring in the course of AFL match play and
diagnosed by a registered medical practitioner
4. Able to initiate infusion of AST-004 within 6 h of concussion
injury.
5. Ability to complete study assessments including
neuropsychological testing without accommodation
6. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participating in an interventional clinical study that may
affect the results of this study (an observational study
acceptable)
2. Subject has had a documented concussion in the previous 6
months
3. Time of concussion injury cannot be accurately determined
4. Females breastfeeding/lactating or with a positive urine
pregnancy test.
5. Known history of end-stage renal disease or receiving
dialysis of any form
6. Known history of seizures including febrile seizures or a first
degree relative with epilepsy
7. Venipuncture not feasible
8. Diagnosis of migraine headaches as per a medical care
provider and which requires prescription medication for
treatment.
9. 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.
10. 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
11. Administration within the past 90 days of darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide.
12. Concussed player that requires a transfer to an emergency
department

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once all inclusion and exclusion criteria are met participants will be randomized to receive AST-004 infusion, high dose, low dose, or placebo (commercially available normal saline) in a 1:1:1 ratio. Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
31/05/2025
Date of last participant enrolment
Anticipated
27/09/2025
Actual
Date of last data collection
Anticipated
25/10/2025
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319054 0
Commercial sector/Industry
Name [1] 319054 0
Astrocyte Pharmaceuticals Pty Ltd
Country [1] 319054 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Astrocyte Pharmaceuticals Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321518 0
None
Name [1] 321518 0
Address [1] 321518 0
Country [1] 321518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317657 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 317657 0
Ethics committee country [1] 317657 0
Australia
Date submitted for ethics approval [1] 317657 0
31/12/2024
Approval date [1] 317657 0
03/03/2025
Ethics approval number [1] 317657 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141722 0
Prof Sepehr Shakib
Address 141722 0
CMAX Clinical Research, Ground Floor, 21-24 North Terrace, Adelaide, South Australia 5000
Country 141722 0
Australia
Phone 141722 0
+61 08 7088 7900
Fax 141722 0
Email 141722 0
[email protected]
Contact person for public queries
Name 141723 0
Lisa Manna
Address 141723 0
Astrocyte Pharmaceuticals Pty Ltd, Level 2, 169 Pirie Street, Adelaide, South Australia 5000
Country 141723 0
Australia
Phone 141723 0
+61 08 7223 0122
Fax 141723 0
Email 141723 0
[email protected]
Contact person for scientific queries
Name 141724 0
Lisa Manna
Address 141724 0
Astrocyte Pharmaceuticals Pty Ltd, Level 2, 169 Pirie Street, Adelaide, South Australia 5000
Country 141724 0
Australia
Phone 141724 0
+61 08 7223 0122
Fax 141724 0
Email 141724 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.