Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
KP-100IT
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Hepatocyte Growth Factor, HGF, KP-100IT, Intrathecal injection
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
- 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
Sites / Locations
- Spinal Injuries Center
- Hokkaido Chuo Rosai Hospital Sekison Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
KP-100IT
Placebo
Arm Description
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times
Outcomes
Primary Outcome Measures
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
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Secondary Outcome Measures
Change of ASIA motor score from baseline at 12 weeks
Time-dependent change of ASIA motor score from baseline
Time-dependent change of ASIA sensory score from baseline
Time-dependent grade change of modified Frankel scale from baseline
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02193334
Brief Title
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2014 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kringle Pharma, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Hepatocyte Growth Factor, HGF, KP-100IT, Intrathecal injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KP-100IT
Arm Type
Active Comparator
Arm Description
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times
Intervention Type
Drug
Intervention Name(s)
KP-100IT
Other Intervention Name(s)
Hepatocyte Growth Factor, HGF
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number and degree of adverse events
Description
Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation
Time Frame
24 weeks
Title
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change of ASIA motor score from baseline at 12 weeks
Time Frame
12 weeks
Title
Time-dependent change of ASIA motor score from baseline
Time Frame
24 weeks
Title
Time-dependent change of ASIA sensory score from baseline
Time Frame
24 weeks
Title
Time-dependent grade change of modified Frankel scale from baseline
Time Frame
24 weeks
Title
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etsuro HASHIMURA
Organizational Affiliation
Kringle Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Spinal Injuries Center
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8508
Country
Japan
Facility Name
Hokkaido Chuo Rosai Hospital Sekison Center
City
Bibai
State/Province
Hokkaido
ZIP/Postal Code
072-0015
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
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