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

Phase 3Not Yet RecruitingNCT07722962

Kringle Pharma, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Spinal Cord Injury (SCI)

Interventions

KP-100ITDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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

Time frame: 24 weeks after investigational product administration