Cosmos Trial: Cerebroprotection Of AST-004 in Mild Complicated Traumatic Brain Injuries
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7.
研究概览
简要总结
This study will evaluate the safety and efficacy of AST-004 as a cerebroprotective treatment for patients with complicated mild TBI.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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-
- •Informed Consent obtained from patient or a legally authorized representative (LAR).
排除标准
- •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
研究组 & 干预措施
AST-004
干预措施: AST-004 (Drug)
Identical to test product except without active substance
干预措施: Identical to test product except without active substance (Drug)
结局指标
主要结局
Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7.
Primary safety endpoint: Safety of different doses of AST-004 as determined by the incidence, frequency, and severity of treatment-emergent adverse events (TEAEs) occurring through Day 7.
Primary pharmacodynamic endpoint: Physiologic effect of AST-004 as determined by the change in plasma GFAP from baseline/pre-dose through the dose-completion, 24 hours, Day 7, Day 14 and Day 30 timepoints. The effect at 24 hours will be of primary interest.
Primary pharmacodynamic endpoint: Physiologic effect of AST-004 as determined by the change in plasma GFAP from baseline/pre-dose through the dose-completion, 24 hours, Day 7, Day 14 and Day 30 timepoints. The effect at 24 hours will be of primary interest.
次要结局
- Clinical effect of AST-004 as determined by change in Rivermead symptom scores from baseline/pre-dose through Day 14.
- Cerebroprotective effect of AST-004 as determined by differences in neuronal integrity, membrane turnover, glial activation, and neuroinflammation, measured as changes in N-acetylaspartate, choline-containing compounds, and myo-inositol on conventional MR spectroscopy at 24 hours and Day 14, and by the difference between these timepoints
研究者
Lisa Manna
Scientific
Astrocyte Pharmaceuticals Inc.