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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• 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 [Срок оценки: 24 weeks after investigational product administration]

Вторичные конечные точки (8)

• Time course of ASIA motor score (total/ upper extremity / lower upper extremity) [Срок оценки: From baseline through 24 weeks]
• Time course of ASIA sensory score [Срок оценки: From baseline through 24 weeks]
• Time course of AIS classification [Срок оценки: From baseline through 24 weeks]
• Time course of modified Frankel classification [Срок оценки: From baseline through 24 weeks]
• Time course of neurological level of injury [Срок оценки: 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 [Срок оценки: 12 weeks and 24 weeks after investigational product administration]
• Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100 after intrathecal administration [Срок оценки: From dosing through 24weeks]
• Evaluation of adverse events [Срок оценки: From the first drug administration through the end of the observation period (24 weeks)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 3 центра

• 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

Идентификаторы

NCT: NCT07722962 · KP-100-ND005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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