Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Phase 2
- Conditions
- cervical compressive myelopathy
- Registration Number
- JPRN-UMIN000011938
- Lead Sponsor
- Department of Orthopedic Surgery, Chiba University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
allergy for G-CSF, history of the malignancy of hematopoietic system, history of malignancy within 5 years, thoromboembolism, splenomegaly, disturbance of consciousness, pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Attenuation of functional impairment 2 weeks after the drug administration using Japanese Orthopedic Association Cervical Myelopathy Evaluation Score (JOA score).
- Secondary Outcome Measures
Name Time Method Attenuation of motor paralysis (ASIA motor score), attenuation of sensory paralysis (ASIA sensory score), attenuation of quality of life (EQ-5D), spinal cord MRI