None listed
Conditions
Brief 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.
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
Sponsors
Astrocyte Pharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed