Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury

UMIN ID: UMIN000018752

Registered date:21/08/2015

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Acute spinal cord injury
• Date of first enrollment: 2015/10/07
• Target sample size: 88
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

filgrastim 400ug/m2/day * 5day
placebo 400ug/m2/day * 5day

Outcome(s)

• Primary Outcome: Transition of motor paralysis(3 months after study drug administration)
• Secondary Outcome: (Efficacy) Change in motor paralysis Change in sensory paralysisThe degree of dysfunction associated with paralysis The proportion of responder to the treatment The level of neurological injury SCIM, EQ-5D (Safety) Frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: (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 have unstable physical status 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.

Related Information

• Primary Sponsor: Chiba University Hospital
• Source(s) of Monetary Support: Japan Medical Association
• Secondary ID(s): JMA-IIA00217