Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor for patients with acute spinal cord injury
- Conditions
- Acute spinal cord injury
- Registration Number
- JPRN-jRCT2091220217
- Lead Sponsor
- Coordinating Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
(1) AIS Grade is B or C at screening
(2) AIS Grade is B or C at re-assessment of neurological status 48 hours (plus-minus 4 hours) after the injury
(3) Neurological level of injury is between C4 and C7
(4) Age betweem 16-85
(5) Patients who give informed consent to participate in the present trial
(6) Patients who can visit 3 months, 6 months, and 12 months after administration
(1) Allergy to filgrastim.
(2) Hematologic malignancy or its previous history
(3) Malignant disease under treatment
(4) invasive treatment for myocardial infarction or angina pectoris within 6 months
(5) previous history of rombosis
(6) splenomegaly.
(7) consciousness disorder.
(8) Patients who are pregnant women, are willing to become pregnant in study period or are lactation.
(9) Neurological disorder which can affect neurological evaluation in the present trial
(10) Patients who receive filgrastim or methylprednisolone sodium succinate after the injury
(11) Patients who are expected to have rapid worsening of symptoms during the trial period
(12) Patients with serious complications
(13) Patients who can not start the rehabilitation in early by complications
(14) Patients with advanced dementia or mental illness
(15) Patients who can not start the rehabilitation in early by multiple trauma or organ damage
(16) Patients who have fracture of extremities, the spine, or the other parts which can affect neurological evaluation in the present trial
(17) Patients who are participating in other trials, or received other study drugs within 12 weeks
(18) In addition, the patient whom investigator judged to be unsuitable as a patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transition of motor paralysis
- Secondary Outcome Measures
Name Time Method Efficacy:<br>Change in motor paralysis<br>Change in sensory paralysis<br>Degree of dysfunction associated with paralysis<br>Proportion of responderpatients that respond to the treatment<br>Neurological level of injury<br>Activity of daily living<br>Quality of Life<br><br>Safety:<br>Frequency of adverse events