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Not yet recruiting NCT07722962

Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

Phase III Interventional Acute Spinal Cord Injury (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KP-100IT.
Who it may be relevant to
Registry conditions: Acute Spinal Cord Injury (SCI). Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury

Overview

This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg/body by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.

Interventions

  • Drug KP-100IT
    The contents of each vial were dissolved in the distilled water for injection, and the study drug (0.6 mg as KP-100) was administered intrathecally once per week a total of 5 times.

Primary outcome measures

  • Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration, 24 weeks [Time frame: 24 weeks after investigational product administration]
Secondary outcome measures (8)
  • Time course of ASIA motor score (total/ upper extremity / lower upper extremity) [Time frame: From baseline through 24 weeks]
  • Time course of ASIA sensory score [Time frame: From baseline through 24 weeks]
  • Time course of AIS classification [Time frame: From baseline through 24 weeks]
  • Time course of modified Frankel classification [Time frame: From baseline through 24 weeks]
  • Time course of neurological level of injury [Time frame: From baseline through 24 weeks]
  • Percentage of subjects improving by at least 5 and 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration [Time frame: 12 weeks and 24 weeks after investigational product administration]
  • Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration [Time frame: From dosing through 24weeks]
  • Evaluation of adverse events [Time frame: From the first drug administration through the end of the observation period (24 weeks)]

Eligibility criteria

Inclusion criteria

  • Patients whose AIS grade is A at 72 hours (± 6 hours) after injury
  • age: 18 years to 89 years
  • MRI imaging and other tests confirm the continuity of the spinal cord

Exclusion criteria

  • The injury site is C1-C2 or C2-C3
  • The patient with a spinal crd compression rate of 70% or higher.
  • The patient in whom a spinal cord rupture is strongle suspected.
  • The patient cannot start rehabilitation necessary for recovery of function at an early stage.
  • External trauma or concurrent organ injury.
  • High dose steroid therapy administered for the treatment of spinal cord injury
  • History or concurrent presence of malignant tumor.
  • It is inappropriate for the subject to be included in the study, in the opinion of the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 3 centers
  • Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries C — Iizuka
  • Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center — Bibai
  • National Hospital Organization Murayama Medical Center — Musashimurayama

Identifiers

NCT: NCT07722962 · KP-100-ND005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗