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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193334
• Other study ID #: KP-100-ND002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 30, 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2019
• Source: Kringle Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 31, 2018
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• KP-100IT

• Placebo

Locations

Country	Name	City	State
Japan	Hokkaido Chuo Rosai Hospital Sekison Center	Bibai	Hokkaido
Japan	Spinal Injuries Center	Iizuka	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kringle Pharma, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks		24 weeks
Secondary	Change of ASIA motor score from baseline at 12 weeks		12 weeks
Secondary	Time-dependent change of ASIA motor score from baseline		24 weeks
Secondary	Time-dependent change of ASIA sensory score from baseline		24 weeks
Secondary	Time-dependent grade change of modified Frankel scale from baseline		24 weeks
Secondary	Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid		6 weeks