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

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

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Masao Koda

University of Tsukuba

1-1-1 Tennodai, Tsukuba-City, Ibaraki 305-8575, JAPAN

masaokod@gmail.com

Tadami Fujiwara

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba-city, Chiba 260-8677, JAPAN

+81-43-202-5730

t-fujiwara@chiba-u.jp

COMPLETED

Oct. 07, 2015

Interventional

A multicenter, confirmatory, parallel group comparative, randomized, double-blind, placebo-controlled study

double blind

Yes

3

(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.

Both

Acute spinal cord injury

Intervention type:DRUG Name of intervention:filgrastim Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per administration:400ug/m2 Dosing frequency / Frequency of use:QD Planned duration of intervention:5days Intended dose regimen:filgrastim 400ug/m2/day * 5day detailes of teratment arms:Administered intravenous drip of Filgrastim (400ug/m2/day) for 5 days in a row. Comparative intervention name:placebo Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per administration:400ug/m2 Dosing frequency / Frequency of use:QD Planned duration of intervention:5days Intended dose regimen:placebo 400ug/m2/day * 5day

Transition of motor paralysis

Efficacy:
Change in motor paralysis
Change in sensory paralysis
Degree of dysfunction associated with paralysis
Proportion of responderpatients that respond to the treatment
Neurological level of injury
Activity of daily living
Quality of Life

Safety:
Frequency of adverse events

+81-43-222-7171

+81-43-226-2629

Feb. 16, 2015