Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury (NCT07722962) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Japan10 participantsStarted 2026-07-31
Plain-language summary
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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 24 weeks after investigational product administration