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

Kringle Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Drug: Placebo; Drug: KP-100IT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02193334

KP-100-ND002

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

KP-100IT

Active Comparator group

Description:

Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times

Treatment:

Drug: KP-100IT

Placebo

Placebo Comparator group

Description:

Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times

Treatment:

Drug: Placebo