Phase 3 study of KP-100IT in subjects with acute spinal cord injury
- Conditions
- Acute spinal cord injury
- Registration Number
- JPRN-UMIN000041030
- Lead Sponsor
- Kringle Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
-The injury site is C1 - C2 or C2 - C3 -The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary -It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury -A history of spinal cord injury (SCI), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI -Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury -High dose steroid therapy administered for spinal cord injury -Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy -History of malignant tumor -Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration -Drug allergies to drugs that will be (or may be) used -Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass -Problems with the subject's ability to give informed consent in person -The subject is breastfeeding or possibly pregnant -The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator -It is inappropriate for the subject to be included in the study, in the judgement of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method