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

Phase 1

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Drug: KP-100IT; Drug: Placebo

• Registration Number: NCT02193334
• Lead Sponsor: Kringle Pharma, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-27
• Study Start: 2014-06-30
• Study First Submitted QC: 2014-07-15
• Study First Posted: 2014-07-17
• Primary Completion: 2017-12-21
• Study Completion: 2018-07-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KP-100IT	KP-100IT	Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Placebo	Placebo	Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid	6 weeks
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

Trial Locations

Locations (2)

Spinal Injuries Center; 🇯🇵 Iizuka, Fukuoka, Japan

Hokkaido Chuo Rosai Hospital Sekison Center; 🇯🇵 Bibai, Hokkaido, Japan