Clinical trial NCT02193334: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Keywords: Hepatocyte Growth Factor
HGF
KP-100IT
Intrathecal injection
Lead sponsor: Kringle Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number and degree of adverse events
timeFrame: 24 weeks
measure: Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Change of ASIA motor score from baseline at 12 weeks
timeFrame: 12 weeks
measure: Time-dependent change of ASIA motor score from baseline
timeFrame: 24 weeks
measure: Time-dependent change of ASIA sensory score from baseline
timeFrame: 24 weeks
measure: Time-dependent grade change of modified Frankel scale from baseline
timeFrame: 24 weeks
measure: Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Iizuka
country: Japan
facility: Spinal Injuries Center
state: Fukuoka
city: Bibai
country: Japan
facility: Hokkaido Chuo Rosai Hospital Sekison Center
state: Hokkaido
Study officials:
affiliation: Kringle Pharma, Inc.
name: Etsuro HASHIMURA
role: STUDY_DIRECTOR
References: