2025-522692-29-00招募中2 期
Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group, Adaptive Proof-of-concept, Dose-selecting Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Intranasal Cenegermin (recombinant human Nerve Growth Factor [rhNGF]) in Adult Participants with subacute moderate to severe Traumatic Brain Injury (TBI).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 42
- 主要终点
- 1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.
研究概览
简要总结
To evaluate the safety and tolerability of intranasal cenegermin in participants with moderate to severe subacute TBI.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male and female adults 18 to 70 years of age.
- •TBI resulting in hospital evaluation within the last 2-8 weeks prior to informed consent
- •A clinical diagnosis of moderate to severe TBI (defined by Glasgow Coma Scale [GCS] score 3 to 12), considering the highest GCS score assessed within 24 hours following injury
- •Confirmed TBI diagnosis by computed tomography (CT) assessed by the investigator
- •Anticipated discharge to a rehabilitation setting within a facility or at home.
排除标准
- •GOS-E score of 7 (lower good recovery) or 8 (upper good recovery) at time of informed consent.
- •Penetrating TBI (eg, gunshot, stabs).
- •Medically refractory brain edema at time of screening.
- •Dependence on invasive mechanical ventilation without the ability to sustain spontaneous breathing at time of screening.
- •Poor survival prognosis (investigator assessment).
- •Pre-existing medical conditions which can continue to produce functional disability up to the time of injury.
研究组 & 干预措施
Cenegermin
Test
干预措施: Cenegermin (Drug)
Vehicle
Placebo
干预措施: Vehicle (Drug)
结局指标
主要结局
1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.
1. Incidence of treatment-emergent serious and non-serious adverse events through 6 months following the first intranasal administration of cenegermin.
次要结局
- 1. Sliding and good outcome in Glasgow Outcome Scale – Extended at month 6.
- 2. Through 12 months following the first administration of investigational product.
- 3. Incidence of treatment-emergent serious and non-serious adverse events, and adverse events of special interest.
- 4. Participant incidence of study discontinuation for tolerability reasons.
- 5. Change from baseline on vital signs, 12-lead ECG results, clinical laboratory assessments, physical examinations, brain MRI, C-SSRS and blood levels of ADA.
研究者
Francisco Martinez Torres
Scientific
Dompe' Farmaceutici S.p.A.
研究点 (42)
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