NCT02053883撤回2 期
A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Cethrin in Subjects With Acute Cervical Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase IIb/III study designed to evaluate the efficacy and safety of Cethrin as a treatment for acute cervical spinal cord injury. During the trial, high and low doses of Cethrin will be compared with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ages 18-62, inclusive
- •Acute cervical spinal cord injury at a neurological level of C4-C6
- •AIS Grade A or B
- •Scheduled to undergo decompression/stabilization surgery within five days of injury
- •Written or verbal consent from patient or legally authorized representative that patient is able and willing to comply with the study protocol, including follow-up visits
排除标准
- •Participation in any other clinical trial for acute SCI, including previous Cethrin trial
- •Inability to receive study medication within five days of injury
- •Acute SCI from gunshot or penetrating/stab wound; peripheral nerve injury; brachial plexus injury; complete spinal cord transection; or multifocal SCI
- •Significant hemorrhage on MRI/CT scan
- •Females who are breastfeeding or have a positive serum pregnancy test
- •Body mass index (BMI) of ≥ 35 kg/m2 at screening
- •History of an adverse reaction to a fibrin sealant or its human or bovine components
- •Use of intravenous heparin in previous 48 hours, aspirin-containing products in previous 24 hours, thrombolytics in previous 12 hours
- •Hemophilia or other bleeding abnormality (platelet level lower than 100 X 109/L, activated partial thromboplastin time or international normalized ratio higher than the upper limit of normal, or baseline hematocrit lower than 0.25)
- •Unconsciousness or other impairment that precludes reliable ASIA examination
- •Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs
- •Clinically significant pre-existing neurological, cardiac, respiratory, hepatic, or renal disease
研究组 & 干预措施
Placebo
Placebo Comparator
Fibrin sealant only.
干预措施: Placebo (Drug)
Cethrin (BA-210) - Low Dose
Experimental
Low dose of Cethrin in a fibrin sealant.
干预措施: Cethrin (BA-210) (Drug)
Cethrin (BA-210) - High Dose
Experimental
High dose of Cethrin in a fibrin sealant.
干预措施: Cethrin (BA-210) (Drug)
结局指标
主要结局
American Spinal Injury Association (ASIA) Upper Extremity Motor Score Recovery
时间窗: Baseline to 6 Months
次要结局
- ASIA Total Motor Score Recovery(Baseline to 6 Months)
- ASIA Impairment Scale (AIS) Grade Recovery(Baseline to 6 Months)
- Motor Neurological Level Recovery(Baseline to 6 Months)
- ASIA Sensory Score Recovery(Baseline to 6 Months)
- Spinal Cord Independence Measure (SCIM) III (Total Score, Self-Care Subscore)(6 Months)
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)(6 Months)
- Incidence of Adverse Events(0-6 Months)
研究者
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