NCT06990867招募中2 期
Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke With Late Presentations
Corxel Pharmaceuticals80 个研究点 分布在 10 个国家目标入组 740 人开始时间: 2025年5月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 740
- 试验地点
- 80
- 主要终点
- Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days
研究概览
简要总结
The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours.
The main question the study aims to answer are:
- JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS.
- Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS.
During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 90 years old.
- •Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).
- •Radiographic evidence of salvageable tissue.
- •Pre-treatment score of NIHSS ≥ 5.
排除标准
- •Radiographic findings pre-randomization of any of the following:
- •Large core infarction, or
- •Occlusion in more than 1 vascular territory, or
- •Significant mass effect or clinically significant cerebral edema, or
- •Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
- •Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
- •Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
- •Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
- •Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000/μL, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds.
- •Major trauma, surgery, or invasive procedures.
- •Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
- •Pre-treatment blood glucose > 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose < 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.
研究组 & 干预措施
Part 1 - JX10 (1mg/kg)
Experimental
干预措施: JX10 (Drug)
Part 1 - JX10 (3mg/kg)
Experimental
干预措施: JX10 (Drug)
Part 1 - Placebo
Placebo Comparator
干预措施: Placebo (Drug)
JX10 Part 2 - (1 or 3 mg/kg)
Experimental
干预措施: JX10 (Drug)
Part 2 - Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days
时间窗: 90 days
Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization
时间窗: Within 36 hours post-randomization
次要结局
- Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days(90 days)
- Incidence of major bleeding within 24 hours and 14 days of study treatment(Within 24 hours and 14 days of study treatment)
- Proportion of participants with functional independence at 90 days(90 days)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(90 days)
研究者
研究点 (80)
Loading locations...
相似试验
终止
2 期
A Study of JNJ-63733657 in Participants With Early Alzheimer's DiseaseAlzheimer DiseaseCognitive DysfunctionDementiaNCT04619420Janssen Research & Development, LLC523
已完成
2 期
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.Attention Deficit Hyperactivity DisorderNCT00566449Johnson & Johnson Pharmaceutical Research & Development, L.L.C.32
已完成
2 期
Study to Evaluate Efficacy, Safety and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder Without Psychiatric ComorbidityInsomniaNCT02464046Janssen Research & Development, LLC28
招募中
2 期
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry EyeDry EyeNCT06296966Vanda Pharmaceuticals40
已完成
2 期
A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related PainPain, BurningPain, CrushingPain, MigratoryPain, RadiatingPain, SplittingNCT00929188Janssen Research & Development, LLC100