Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Starting soon · Phase 3
Conditions studied: Acute Spinal Cord Injury (SCI)
In brief
This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.
Key facts
- Study ID
- NCT07722962
- Run by
- Kringle Pharma, Inc.
- People needed
- 10
- Starts
- 2026-07-31
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients whose AIS grade is A at 72 hours (± 6 hours) after injury
- age: 18 years to 89 years
- MRI imaging and other tests confirm the continuity of the spinal cord
You may not qualify if…
- The injury site is C1-C2 or C2-C3
- The patient with a spinal crd compression rate of 70% or higher.
- The patient in whom a spinal cord rupture is strongle suspected.
- The patient cannot start rehabilitation necessary for recovery of function at an early stage.
- External trauma or concurrent organ injury.
- High dose steroid therapy administered for the treatment of spinal cord injury
- History or concurrent presence of malignant tumor.
- It is inappropriate for the subject to be included in the study, in the opinion of the investigator.
Where it is running
- Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center — Iizuka, Fukuoka, Japan
- Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center — Bibai, Hokkaido, Japan
- National Hospital Organization Murayama Medical Center — Musashimurayama, Tokyo, Japan
Full record on ClinicalTrials.gov
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