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

ConditionAcute Spinal Cord Injury (SCI)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-89
SponsorKringle Pharma, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • KP-100IT

    Drug

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: KP-100ITExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
24 weeks after investigational product administration

Secondary outcomes

1

Time course of ASIA motor score (total/ upper extremity / lower upper extremity)

Time frame
From baseline through 24 weeks
2

Time course of ASIA sensory score

Time frame
From baseline through 24 weeks
3

Time course of AIS classification

Time frame
From baseline through 24 weeks
4

Time course of modified Frankel classification

Time frame
From baseline through 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kringle Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: