UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031135 |
|---|---|
| Receipt number | R000035548 |
| Scientific Title | Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2024/08/10 10:25:25 |
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Basic information
Public title
Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients
Acronym
An open treatment trial of NMO with MMF
Scientific Title
Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients
Scientific Title:Acronym
An open treatment trial of NMO with MMF
Region
| Japan |
Condition
Condition
Neuromyelitis Optica
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mycophenolate mofetil is an antimetabolite that has been found to suppress recurrence of Neuromyelitis Optica. In Japan, single steroid is commonly used for the treatment of Neuromyelitis Optica. In this study, we are aiming to demonstrate a treatment method with fewer side effects by using Mycophenolate mofetil in combination with steroid.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess the effect of Mycophenolate mofetil suppressing the recurrence of Neuromyelitis optics for 1 year
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mycophenolate mofetil treatment for 1 year
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stable Neuromyelitis Optica patients with EDSS score less than 7.0 who wish to participate in this study
Key exclusion criteria
1. Patients with infection
2. Patients with pregnancy or breast-feeding
3. Patients who take any immunosuppressant other than steroid
4. patients with severe liver or kidney dysfunction
5. patients with a history of cancer within 5 years
6. In addition, patients judged inappropriate by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Sekiguchi |
Organization
Kobe University Hospital
Division name
Neurology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5885
sekiguch@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Chihara |
Organization
Kobe University Hospital
Division name
Neurology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5885
Homepage URL
med3@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.tandfonline.com/doi/full/10.1080/25785826.2024.2304364
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/25785826.2024.2304364
Number of participants that the trial has enrolled
9
Results
The study included nine patients with NMOSD who received MMF along with prednisolone dose reduction. MMF was effective in achieving prednisolone dose reduction without relapse in 77.8% of patients, with a significant reduction in the mean annualized relapse rate. All adverse events were mild. The results suggest that MMF may be a viable treatment option for middle-aged and older patients who require steroid reduction.
Results date posted
| 2024 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Described in the manuscript
Participant flow
Described in the manuscript
Adverse events
Described in the manuscript
Outcome measures
Described in the manuscript
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035548
