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Cosmos Trial: Cerebroprotection Of AST-004 in Mild Complicated Traumatic Brain Injuries
EU CTIS ID: 2026-525554-11-00
What this study is testing
This study will evaluate the safety and efficacy of AST-004 as a cerebroprotective treatment for patients with complicated mild TBI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult - age 18-70 years
- Complicated-mild TBI - defined as Glasgow Coma Scale (GCS) 13-15 with traumatic lesions on head CT scan obtained in the ED.
- Subject has minor or no extracranial injuries
- Injuries do not require admission to an intensive care unit
- Able to initiate treatment with AST-004 within 12h from injury.
- Male and female participants of childbearing potential must agree to use an effective method of birth control or abstain from sexual relations that could result in pregnancy for 14 days after receiving treatment with AST-004.
You likely can't join if
- Current enrollment in another interventional, therapeutic clinical study that may affect the results of this study (an observational study is acceptable)
- Administration of, or plans for, a blood transfusion during study participation
- Current abuse of any drugs that are illegal under the Dutch country law.
- Administration within the past 90 d of darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide or need to administer these medications during the first 48 hours post-dose
- Subject is under the influence of alcohol, any stimulant, nitrates, mind alternating illicit drug or of alternative medications or supplements with stimulant properties (e.g., ephedra) or vasodilatory properties (e.g., nitrate containing supplements) and in the opinion of the Investigator alters ability to complete study assessments and/or study results
- Prior TBI within the previous 6 months.
See the full eligibility criteria
- Adult - age 18-70 years
- Complicated-mild TBI - defined as Glasgow Coma Scale (GCS) 13-15 with traumatic lesions on head CT scan obtained in the ED.
- Subject has minor or no extracranial injuries
- Injuries do not require admission to an intensive care unit
- Able to initiate treatment with AST-004 within 12h from injury.
- Male and female participants of childbearing potential must agree to use an effective method of birth control or abstain from sexual relations that could result in pregnancy for 14 days after receiving treatment with AST-004.
- Informed Consent obtained from patient or a legally authorized representative (LAR).
- Current enrollment in another interventional, therapeutic clinical study that may affect the results of this study (an observational study is acceptable)
- Administration of, or plans for, a blood transfusion during study participation
- Current abuse of any drugs that are illegal under the Dutch country law.
- Administration within the past 90 d of darolutamide, eltrombopag, febuxostat, fostamatinib, teriflunomide or need to administer these medications during the first 48 hours post-dose
- Subject is under the influence of alcohol, any stimulant, nitrates, mind alternating illicit drug or of alternative medications or supplements with stimulant properties (e.g., ephedra) or vasodilatory properties (e.g., nitrate containing supplements) and in the opinion of the Investigator alters ability to complete study assessments and/or study results
- Prior TBI within the previous 6 months.
- Non-Dutch or English speaking ability or illiteracy that would interfere with understanding follow-up questionnaires
- Time of injury cannot be determined
- Females breastfeeding/lactating or with a positive pregnancy test.
- Patients who require acute surgical and/or neurosurgical interventions or sedation requiring endotracheal intubation
- Participant has a pre-injury cognitive impairment that prevents them from completing clinical assessments as required
- Known end-stage renal disease or receiving dialysis of any form
- Venipuncture not feasible
- Known history of seizures including febrile seizures or a first degree relative with epilepsy
- Subject has a major neurological (e.g., a history of a brain tumor, neurosurgery, stroke or transient ischemic attack (TIA), etc.) or psychiatric/behavioral disorder co-morbidity
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.