Optimizing Reperfusion to Improve Outcomes and Neurologic Function
Part of paid clinical trials in Long Beach, California.
- Sponsor
- Corxel Pharmaceuticals
- Study ID
- NCT06990867
- Phase
- PHASE2/PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- JX10 — DRUGJX10 is a thrombolytic agent.
- Placebo — DRUGPlacebo is being used as the comparator.
Study Details
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: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. 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.
Key Dates
- Start date
- May 15, 2025
- Status verified
- Oct 2025
- Primary completion
- Oct 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 740 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1 - JX10 (1mg/kg)
- Experimental: Part 1 - JX10 (3mg/kg)
- Placebo Comparator: Part 1 - Placebo
- Experimental: JX10 Part 2 - (1 or 3 mg/kg)
- Placebo Comparator: Part 2 - Placebo
Primary Outcome Measure
Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days [ Time Frame: 90 days ]
Central Contacts
- Corxel Pharmaceuticals Study Information Center201-268-3723
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Corxel Investigational Site | Long Beach | California | 90806 | |
| Corxel Investigational Site | Sacramento | California | 95817 | |
| Corxel Investigational Site | Colorado Springs | Colorado | 80909 | |
| Corxel Investigational Site | Washington D.C. | District of Columbia | 20007 | |
| Corxel Investigational Site | Delray Beach | Florida | 33484 | |
| Corxel Investigational Site | Chicago | Illinois | 60616 | Study Director |
| Corxel Investigational Site | Wichita | Kansas | 67214 | |
| Corxel Investigational Site | Baltimore | Maryland | 21215 | |
| Corxel Investigational Site | Kalamazoo | Michigan | 49048 | |
| Corxel Investigational Site | Traverse City | Michigan | 49684 | |
| Corxel Investigational Site | St Louis | Missouri | 63110 | |
| Corxel Investigational Site | Great Neck | New York | 11021 | |
| Corxel Investigational Site | New York | New York | 10029 | |
| Corxel Investigational Site | Toledo | Ohio | 43606 | |
| Corxel Investigational Site | Tulsa | Oklahoma | 74104 | |
| Corxel Investigational Site | Dallas | Texas | 75246 | |
| Corxel Investigational Site | Houston | Texas | 77030 |
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