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Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

Not Yet RecruitingPhase 3

Sponsor: Kringle Pharma, Inc.

Conditions: Acute Spinal Cord Injury (SCI)

Interventions: KP-100IT

Countries: Japan

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 overview

Sex: ALL

Age: 18 Years to 89 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Iizuka, Fukuoka, Japan
Bibai, Hokkaido, Japan
Musashimurayama, Tokyo, Japan