Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients

JRCT ID: jRCTs051180080

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuromyelitis optica
• Date of first enrollment: 12/12/2018
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Mycophenolate mofetil treatment for 1 year

Outcome(s)

• Primary Outcome: Whether the steroid dose is halved according to the treatment protocol 1 year after starting Mycophenolate mofetil and there is no clinical relapse with this combination therapy.

Secondary Outcome

Decreased steroid dose
The number of radiological relapse
Changes in EDSS score
Neuro-ophthalmologic examination
Safety assessment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both
• Include criteria: Stable Neuromyelitis Optica patients with EDSS score less than 7.0 who wish to participate in this study

Exclude 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 (including carcinoma in situ)
6. In addition, patients judged inappropriate by the investigators

Related Information

• Primary Sponsor: Sekiguchi Kenji
• Secondary ID(s): UMIN000031135