臨床研究等提出・公開システム

Date of registration	Nov. 10, 2021
Last modified on	Nov. 10, 2021
Trial ID	jRCT1030210419

Scientific Title	Study on the effect of disease modifiers on pain, fatigue and quality of life (QOL) in patients with neuromyelitis optica spectrum disorder (NMOSD)
Public Title	Study on the effect of disease modifiers on pain, fatigue and quality of life in patients with NMOSD

Contact for Scientific Queries	Name	Kazuhiro Ishii
	Affiliation	University of Tsukuba
	Address	1-1-1 Ten'noudai, Tsukuba, Ibaraki
	Telephone	+81-29-853-3204
	E-mail	kazishii@md.tsukuba.ac.jp
Contact for Public Queries	Name	Kazuhiro Ishii
	Affiliation	University of Tsukuba
	Address	1-1-1 Ten'noudai, Tsukuba, Ibaraki
	Telephone	+81-29-853-3204
	E-mail	kazishii@md.tsukuba.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Nov. 10, 2021
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	The NMOSD diagnosis follows the diagnostic criteria of Wingerchuk et al. (Wingerchuk DM 2007, 2015). The subjects were patients who were diagnosed, treated, or newly diagnosed with neuromyelitis optica spectrum disorder (NMOSD) at our hospital from September 2020 to March 31, 2022. Patients who started administration of oral steroid humanized monoclonal antibody (Satralizumab, etc.) as a therapeutic intervention.
	Exclusion Criteria	Minors (under 20 years old)
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Neuromyelitis Optica Spectrum Disorders
Health Condition(s) Keyword		NMOSD, Humanized monoclonal antibody, pain, fatigue, QOL
Health Condition(s) Code		D009471
Primary Outcome(s)		Evaluation / measurement of motor function, ADL, disability, QOL, pain, fatigue, and depressive symptoms

Primary Sponsor	University of Tsukuba

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Clinical Research Ethics Review Committee
Address	1-1-1 Ten'noudai, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-credo.adm@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Sept. 17, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none