Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury

Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury - Phase I/II study of KP-100IT in acute spinal cord injury

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014434

Enrollment

Registered

2014-06-30

Start date

2014-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Interventions

Intrathecal injection of KP-100IT Intrathecal injection of placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Spinal cord injury at cervical level -Grade A, B1 or B2 in the modified Frankel scale at 72 hours since the injury. -Patients able to provide written informed consent, which may require a reltative to sign if arm/hand function is compromised.

Exclusion criteria

Exclusion criteria: -Spinal cord injury at C1-C2 or C2-C3 level -Patients not 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, abnormality in spinal cavity, or considerable meningeal damage -Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries -High-dose steroid therapy within 30 days before the entry -Patients who have diseases such as serious liver disorder, renal disorder, heart 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 drugs scheduled to be used in the study -Administration of the study drug to the area of spinal cord injury is not appropriate because of 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

Design outcomes

Primary

Measure	Time frame
Adverse events Change of ASIA motor score from baseline at 24 weeks	—

Secondary

Measure	Time frame
ASIA sensory score Grade change of modified Frankel scale Concentration of KP-100 in plasma and cerebrospinal fluid	—

Countries

Japan

Contacts

Public ContactDaichika, Hayata

Kringle Pharma, Inc. Department of Pharmaceutical Development

hayata@kringle-pharma.com072-641-8739

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026