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 — DRUG
    JX10 is a thrombolytic agent.
  • Placebo — DRUG
    Placebo 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

Locations (17)

FacilityCityStateZIPSite coordinators
Corxel Investigational SiteLong BeachCalifornia90806
Study Director
201-268-3723
Corxel Investigational SiteSacramentoCalifornia95817
Study Director
201-268-3723
Corxel Investigational SiteColorado SpringsColorado80909
Study Director
201-268-3723
Corxel Investigational SiteWashington D.C.District of Columbia20007
Study Director
201-268-3723
Corxel Investigational SiteDelray BeachFlorida33484
Study Director
201-268-3723
Corxel Investigational SiteChicagoIllinois60616
Study Director
Corxel Investigational SiteWichitaKansas67214
Study Director
201-268-3723
Corxel Investigational SiteBaltimoreMaryland21215
Study Director
201-268-3723
Corxel Investigational SiteKalamazooMichigan49048
Study Director
201-268-3723
Corxel Investigational SiteTraverse CityMichigan49684
Study Director
201-268-3723
Corxel Investigational SiteSt LouisMissouri63110
Study Director
201-268-3723
Corxel Investigational SiteGreat NeckNew York11021
Study Director
201-268-3723
Corxel Investigational SiteNew YorkNew York10029
Study Director
201-268-3723
Corxel Investigational SiteToledoOhio43606
Study Director
201-268-3723
Corxel Investigational SiteTulsaOklahoma74104
Study Director
201-268-3723
Corxel Investigational SiteDallasTexas75246
Study Director
201-268-3723
Corxel Investigational SiteHoustonTexas77030
Study Director
201-268-3723

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