Acute Spinal Cord Injury (SCI)
Conditions
Keywords
KP-100IT, Hepatocyte growth factor, Intrathecal administration
Brief summary
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.
Interventions
DRUGKP-100IT
The contents of each vial were dissolved in the distilled water for injection, and the study drug (0.6 mg as KP-100) was administered intrathecally once per week a total of 5 times.
Sponsors
Kringle Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks | 24 weeks after investigational product administration |
Secondary
| Measure | Time frame |
|---|---|
| Time course of ASIA motor score (total/ upper extremity / lower upper extremity) | From baseline through 24 weeks |
| Time course of ASIA sensory score | From baseline through 24 weeks |
| Time course of AIS classification | From baseline through 24 weeks |
| Time course of modified Frankel classification | From baseline through 24 weeks |
| Time course of neurological level of injury | From baseline through 24 weeks |
| Percentage of subjects improving by at least 5 and 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration | 12 weeks and 24 weeks after investigational product administration |
| Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration | From dosing through 24weeks |
| Evaluation of adverse events | From the first drug administration through the end of the observation period (24 weeks) |
Countries
Japan
Contacts
CONTACTDaichika Hayata
CONTACTYurika Abe
Outcome results
None listed