UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury
Acronym	G-CSF mediated spinal cord injury recovery induction trial(G-SPIRIT)
Scientific Title	Randomized, placebo-controlled, double-blind, parallel group comparative, phase 3 study of granulocyte-colony stimulating factor in patients with acute spinal cord injury
Scientific Title:Acronym	G-CSF mediated spinal cord injury recovery induction trial(G-SPIRIT)
Region	Japan

Condition
Condition	Acute spinal cord injury
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present trial is to elucidate therapeutic efficacy of G-CSF for motor paralysis of acute spinal cord injury
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Transition of motor paralysis(3 months after study drug administration)
Key secondary outcomes	(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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	filgrastim 400ug/m2/day * 5day
Interventions/Control_2	placebo 400ug/m2/day * 5day
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	(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 1 month, 3 months, 6 months, and 12 months after administration
Key exclusion 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.
Target sample size	88

Research contact person
Name of lead principal investigator	1st name Seiji Middle name Last name Ohtori
Organization	Chiba University Hospital
Division name	Department of Orthopaedic Surgery
Zip code	2608677
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-226-2117
Email	G-SPIRIT@ml.chiba-u.jp

Public contact
Name of contact person	1st name Tadami Middle name Last name Fujiwara
Organization	Chiba University Hospital
Division name	Chiba Clinical Research Center
Zip code	2608677
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	t-fujiwara@chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Japan Medical Association
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Hospital IRB
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel	043-222-7171
Email	G-SPIRIT@ml.chiba-u.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	JMA-IIA00217
Org. issuing International ID_1	Japan Medical Association
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 05 Day
Date of IRB	2015 Year 02 Month 18 Day
Anticipated trial start date	2015 Year 10 Month 07 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2019 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021694