A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
Overview
- Phase
- Phase 1
- Intervention
- KP-100IT
- Conditions
- Spinal Cord Injuries
- Sponsor
- Kringle Pharma, Inc.
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Intervention: KP-100IT
Placebo
Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times
Intervention: Placebo
Outcomes
Primary Outcomes
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Time Frame: 24 weeks
Number and degree of adverse events
Time Frame: 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 Outcomes
- 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)