UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051728 |
|---|---|
| Receipt number | R000059041 |
| Scientific Title | Treatment Preference in Patients with NMOSD |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2023/07/27 18:46:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Treatment Preference in Patients with NMOSD
Acronym
Treatment Preference in Patients with NMOSD
Scientific Title
Treatment Preference in Patients with NMOSD
Scientific Title:Acronym
Treatment Preference in Patients with NMOSD
Region
| Japan |
Condition
Condition
Neuromyelitis Optica Spectrum Disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To structure the causal relationship between NMOSD patients' subjective adverse event experience and impact on daily life and to quantify treatment choices and preferences in NMOSD patients
Basic objectives2
Others
Basic objectives -Others
Patients' treatment preference
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Causal Relationship between Subjective Adverse Event Experience and Impact on Daily Living of Patients with NMOSD
Key secondary outcomes
Subjective Adverse Event Experience and Importance of Impact on Daily Living of Patients with NMOSD
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who meet all of the following criteria:
(1)Documented diagnosis of NMOSD
(2)Anti-aquaporin-4 antibody test positive
(3)Patients who are taking or have taken an oral steroid
(4)Patients aged 20 years or older at the time of enrollment
(5)Must have sufficient understanding to conduct the research (The patient may require assistance in reading aloud, etc. due to visual disturbance.)
(6)Individuals who have consented to participate in this research
(7)People who are living in Japan at the time of enrollment
(8)Individuals who have equipment/communication environment to apply for research participation online and perform interviews or respond to questionnaires
Key exclusion criteria
Subjects who meet any of the following criteria:
(1)Persons who have difficulty in obtaining consent or conducting this research due to a lack of Japanese ability
(2)People who cannot participate in the survey
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KATSUHISA |
| Middle name | |
| Last name | YAMASHITA |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Div. Specialty Medical Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-chome, Nihonbashi Mitsui Tower (Reception15F) Chuo-ku, Tokyo
TEL
0332816611
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | TADASHI |
| Middle name | |
| Last name | NAGATSUKA |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Div. Specialty Medical Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-chome, Nihonbashi Mitsui Tower (Reception15F) Chuo-ku, Tokyo
TEL
0332816611
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo 108-0073
Tel
03-6416-1868
npo-mins@j-irb.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to clarify treatment selection factors in patients with NMOSD
Management information
Registered date
| 2023 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059041
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
