UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Title of the study (Brief title)	Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy: multicenter placebo controlled randomized single blinded trial.
Region	Japan

Condition
Condition	cervical compressive myelopathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the efficacy of granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute aggravation of cervical compressive myelopathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Attenuation of functional impairment 2 weeks after the drug administration using Japanese Orthopedic Association Cervical Myelopathy Evaluation Score (JOA score).
Key secondary outcomes	Attenuation of motor paralysis (ASIA motor score), attenuation of sensory paralysis (ASIA sensory score), attenuation of quality of life (EQ-5D), spinal cord MRI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Granulocyte colony-stimulating factor
Interventions/Control_2	normal saline
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Acute aggravation of cervical compressive myelopathy (who showed 2 pts. deterioration of JOA score within 1 month), patients with the voluntary consent documents upon participation, patients who can visit the hospital for one year
Key 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
Target sample size	60

Research contact person
Name of lead principal investigator	Takeo Furuya
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedics
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2961
Email	takeo251274@yahoo.co.jp

Public contact
Name of contact person	Yukiko Matsumoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedics
Address	1-8-1 Inohana, Chuo-ku, Chiba
TEL	043-226-2961
Homepage URL
Email	chibaseikei8f@yahoo.co.jp

Sponsor
Institute	Department of Orthopedic Surgery, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 17 Day
Anticipated trial start date	2013 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013939