Phase I/II Study of KP-100IT in Acute Spinal Cord Injury

A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury

This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Placebo; Drug: KP-100IT

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8508
      • Spinal Injuries Center
  • Hokkaido
    • Bibai, Hokkaido, Japan, 072-0015
      • Hokkaido Chuo Rosai Hospital Sekison Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age equal to or greater than 18 years and equal to or less than 75 years
• Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury
• Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised

Exclusion Criteria:

• Spinal cord injury at C1-C2 0r C2-C3 level
• Patients not to able to start rehabilitation within a week by setup of respirator or other reason
• First dose of the study drug will not be given within 78 hours since the injury
• History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage
• Outcome assessment will not be conducted adequately through damage on injuries other than the injury
• High-dose steroid therapy within 30 days before the entry
• Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections
• History of malignant tumor
• Patients who participated in other clinical study within 30 days before the entry
• Patients who have allergies to drug scheduled to be used in the study
• Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor
• Patients not able to understand "informed consent" properly
• Patients who are nursing or may be pregnant
• Investigator considers that the patient is not appropriate for participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: KP-100IT; Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times	Drug: KP-100IT; Other Names: Hepatocyte Growth Factor; HGF
Placebo Comparator: Placebo; Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and degree of adverse events	Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation	24 weeks
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks		24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of ASIA motor score from baseline at 12 weeks	12 weeks
Time-dependent change of ASIA motor score from baseline	24 weeks
Time-dependent change of ASIA sensory score from baseline	24 weeks
Time-dependent grade change of modified Frankel scale from baseline	24 weeks
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid	6 weeks

Collaborators and Investigators

• Sponsor: Kringle Pharma, Inc.
• Investigators: Study Director: Etsuro HASHIMURA, Kringle Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2014
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: HGF; Hepatocyte Growth Factor; KP-100IT; Intrathecal injection
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: KP-100-ND002