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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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519521-37-01
Acronym
JX10002
Enrollment
287
Registered
2025-06-23
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Brief summary

Efficacy: Proportion of participants with no or minimal symptoms at 90 days., Safety: Incidence of symptomatic intracranial hemorrhage, defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and or intraventricular hemorrhage within 36 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline (the closest collection before administration of the study treatment), or from the lowest NIHSS value between baseline and 24 hours, or leading to death.

Interventions

DRUGJX10
DRUGJx10 placebo drug product is prepared as a sterile
DRUGlyophilized white to light yellow cake or powder for infusion.

Sponsors

Corxel Pharmaceuticals Co. Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Efficacy: Proportion of participants with no or minimal symptoms at 90 days., Safety: Incidence of symptomatic intracranial hemorrhage, defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and or intraventricular hemorrhage within 36 hours post-randomization, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline (the closest collection before administration of the study treatment), or from the lowest NIHSS value between baseline and 24 hours, or leading to death.

Countries

Belgium, Bulgaria, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026