Status: Not yet recruiting
Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
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.
Participants needed: 10
Trial details
Phase: Phase 3Age: 18-89Biological sex: AllType: InterventionalSponsor: Kringle Pharma, Inc.Updated: Jul 23, 2026Locations: 3
Eligibility criteria
Patients whose AIS grade is A at 72 hours (± 6 hours) after injury [+2]
The injury site is C1-C2 or C2-C3 [+7]