Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
ConditionAcute Spinal Cord Injury (SCI)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-89
SponsorKringle Pharma, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- KP-100IT
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov