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 2023/02/08 17:55:37

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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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

9

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

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

2023 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035548


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name