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NCT Number: NCT02193334

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Deafness, Autosomal Recessive 39 Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Spinal Injuries Center, Iizuka, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KP-100IT

Drug

Other names: Hepatocyte Growth Factor, HGF

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kringle Pharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jul 17, 2014
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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