NCT02669849终止2 期
A Phase 2b/3, Double-blind, Randomized, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic 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
- 终止
- 入组人数
- 70
- 主要终点
- Change in Upper Extremity Motor Score (UEMS)
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:
- •Screening UEMS score must be ≤16 points on each side.
- •AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side.
- •AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side.
- •American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.
- •Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.
- •Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.
排除标准
- •Participation in any other clinical study for acute SCI without approval by the sponsor.
- •Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
- •One or more upper extremity muscle groups untestable during screening ISNCSCI examination.
- •Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
- •Females who are breastfeeding or have a positive serum pregnancy test.
- •Body mass index (BMI) of ≥40 kg/m^2 at screening.
- •History of an adverse reaction to a fibrin sealant or its components.
- •Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
- •Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
- •Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator.
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VX-210
Experimental
干预措施: VX-210 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Upper Extremity Motor Score (UEMS)
时间窗: From baseline at 6 months post-treatment
UEMS focuses selectively on the hand and arm control most relevant to individuals with a cervical spinal cord injury. UEMS ranges from 0 to 50, where a higher score indicates a better movement of hand and arm.
次要结局
- Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score(At 6 months post-treatment)
- Spinal Cord Independence Measure (SCIM) III Self-Care Subscore(At 6 months post-treatment)
- Capabilities of Upper Extremity Test (CUE-T) Score(At 6 months post-treatment)
- Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders(At 6 months post-treatment)
- Percentage of Motor Level Responders(At 6 months post-treatment)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210(up to 53 hours post-treatment)
- Maximum Observed Plasma Concentration (Cmax) of VX-210(up to 53 hours post-treatment)
- Area Under Plasma Concentration Time Curve (AUC) of VX-210(up to 53 hours post-treatment)
研究者
相似试验
已完成
2 期
A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702Rheumatoid ArthritisNCT00395577Vertex Pharmaceuticals Incorporated120
已完成
2 期
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06603077Avalo Therapeutics, Inc.253
已完成
2 期
A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationCystic FibrosisNCT02709109Parion Sciences147
进行中（未招募）
2 期
VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative ColitisColitis, UlcerativeNCT05156125Oppilan Pharma Ltd213
终止
2 期
VTX958 Versus Placebo for the Treatment of Moderate to Severe PsoriasisPsoriasisNCT05655299Ventyx Biosciences, Inc222