A Parallel Group Treatment, Phase 2A, Double-blind, 3-arm Study to Investigate Safety and Efficacy of ABX-101 Compared With Placebo in Male and Female Participants, Aged 18 to 50 Years, With Moderate-to-severe Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Glasgow Outcome Scale-Extended (GOS-E)
研究概览
简要总结
The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants with moderate to severe TBI.
详细描述
Study details include:
- The study duration will be up to 180 days per participant.
- The treatment duration will be up to 7 days.
- The visits post-treatment will be on day 30 and day 180 of the study.
Number of Participants:
A maximum of 45 participants will be enrolled into the study and randomized to each treatment arm in a ratio of 1:1:1. i.e., fifteen participants per arm.
Study Arms and Duration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements
- •18 - 50 years of age, inclusive
- •Expected to survive more than 24 hours after admission
- •Clearly defined time of injury no more than 12 hours before administration of study drug/placebo
- •o Subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs
- •TBI with Glasgow Coma Score (GCS) 4-12 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician
- •o Subjects stratified 1:1 (in each arm) by GCS 4-8 and GCS 9-12
- •Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP
- •[Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable]
排除标准
- •Penetrating head injury (e.g. missile, stab wound)
- •Concurrent, but not pre-existing, spinal cord injury
- •Not expected to survive more than 24 hours after admission
- •Pregnant, or a positive pregnancy test
- •Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
- •Patient pupils are unresponsive (dilation) in both eyes
- •The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
- •Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning
- •Known or CT scan evidence of pre-existing major cerebral damage
- •Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
- •Known to have received an experimental drug within 4 weeks prior to current injury
- •Patients who cannot be monitored with regard to their recovery (GOS-E and QOLIBRI)
研究组 & 干预措施
Experimental: ABX-101 1mg
Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).
Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other).
The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
干预措施: ABX-101 1mg (Drug)
Experimental: ABX-101 1mg
Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).
Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other).
The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
干预措施: ABX-101 2mg (Drug)
Experimental: ABX-101 2mg
Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).
Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other).
The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
干预措施: ABX-101 2mg (Drug)
Experimental: ABX-101 2mg
Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).
Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other).
The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX 101 (1 mg OR 2 mg) intramuscular injections, is seven days.
干预措施: ABX-101 1mg (Drug)
Placebo Comparator: Saline
Placebo to the ABX-101 will be administered to patients.
干预措施: ABX-101 1mg (Drug)
Placebo Comparator: Saline
Placebo to the ABX-101 will be administered to patients.
干预措施: ABX-101 2mg (Drug)
结局指标
主要结局
Glasgow Outcome Scale-Extended (GOS-E)
时间窗: 180 days
To demonstrate superiority of ABX-101 vs placebo on the Glasgow Outcome Scale-Extended (GOS-E) at 90-days in participants with TBI
次要结局
- Glasgow Outcome Scale-Extended (GOS-E)(30 days)
- Glasgow Coma Score (GSC) improvement(7 days)
- Quality of life- (QOLIBRI)(180 days)
- GFAP Inflammatory Biomarker Analysis(7 days)
- ICP Maintenance(7 days)
- Neuroworsening(7 days)
- Mortality(180 days)
- Midline Shift(3 days)
- Adverse Events(7 days)
- Therapeutic Intensity Level(7 days)