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

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ClinicalTrials.gov Identifier: NCT02193334
Recruitment Status : Unknown
Verified March 2015 by Kringle Pharma, Inc..
Recruitment status was:  Recruiting
First Posted : July 17, 2014
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Kringle Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: KP-100IT Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Drug: KP-100IT
Other Names:
  • Hepatocyte Growth Factor
  • HGF

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



Primary Outcome Measures :
  1. 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

  2. Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change of ASIA motor score from baseline at 12 weeks [ Time Frame: 12 weeks ]
  2. Time-dependent change of ASIA motor score from baseline [ Time Frame: 24 weeks ]
  3. Time-dependent change of ASIA sensory score from baseline [ Time Frame: 24 weeks ]
  4. Time-dependent grade change of modified Frankel scale from baseline [ Time Frame: 24 weeks ]
  5. Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193334


Contacts
Contact: Tetsushi Abe, DVM +81-72-641-8739 abe@kringle-pharma.com
Contact: Kazuhiro Fukuta, PhD +81-72-641-8739 fukuta@kringle-pharma.com

Locations
Japan
Spinal Injuries Center Recruiting
Iizuka, Fukuoka, Japan, 820-8508
Contact: Takeshi Maeda, MD, PhD    +81-948-24-7500      
Principal Investigator: Takeshi Maeda, MD, PhD         
Hokkaido Chuo Rosai Hospital Sekison Center Recruiting
Bibai, Hokkaido, Japan, 072-0015
Contact: Kota Suda, MD, PhD    +81-126-63-2151      
Principal Investigator: Kota Suda, MD, PhD         
Sponsors and Collaborators
Kringle Pharma, Inc.
Investigators
Study Director: Tetsushi Abe, DVM Kringle Pharma, Inc.

Responsible Party: Kringle Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02193334     History of Changes
Other Study ID Numbers: KP-100-ND002
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: March 2015

Keywords provided by Kringle Pharma, Inc.:
Hepatocyte Growth Factor
HGF
KP-100IT
Intrathecal injection

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action