Feb. 27, 2019 |
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Mar. 30, 2022 |
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jRCTs051180080 |
Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients (An open treatment trial of NMO with MMF) |
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Treatment of Neuromyelitis Optica with Mycophenolate Mofetil in Japanese Patients (An open treatment trial of NMO with MMF) |
Aug. 10, 2021 |
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9 |
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The mean age of 9 patients was 56.4 years old (standard deviation(SD), 8.92 years), all of the patients were women, median disease duration was 68 months (9-84), and the mean number of recurrences over the last 2 years was 1.33 (SD, 1.22), the average number of recurrences in the past is 3.56 (SD, 2.27). The amount of oral prednisolone was 5-10 mg / day for 3 patients and 11-20 mg / day for other 6 patients. The average EDSS score was 2.9 (SD 2.2). |
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Ten patients were screened. One was excluded by the age limiation, and finally 9 patients were enrolled. |
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A total of 10 adverse reactions, such as upper respiratory tract infection (2 cases), were reported during the study period, but all were mild (CTCAE Grade 1). |
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During the study period, 2 patients showed clinical recurrence and dropped out from the study, but 7 (77.8%, 95% CI (0.46%, 97.3%)) achieved the primary endpoint. The average number of recurrences per year during the study period decreased from 0.67 to 0.22 (p < 0.05, paired t test). On the other hand, the amount of oral prednisolone was reduced from an average of 13.3 mg / day to 5.00 mg / day. In addition, EDSS did not show a significant change from 2.43 to 2.35 on average (p = 0.36, paired t test). |
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MMF was effective for preventing relapse of neuromyelitis optica spectrum disorders with concomitant half dose oral corticosteroid reduction in 7/9 (77.8%, 95%CI (0.46%, 97.3%)) patients. MMF induction ameliorated cognitive tests scores without exacerbating EDSS scores. There were no cases of discontinuation of MMF due to adverse effects. |
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Feb. 18, 2022 |
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Yes |
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We have a plan to share IPD after publication of the results. |
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https://jrct.niph.go.jp/latest-detail/jRCTs051180080 |
Sekiguchi Kenji |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe City |
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+81-78-382-5885 |
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neuro@med.kobe-u.ac.jp |
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Chihara Norio |
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Kobe University Hospital |
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7-5-2, Kusunoki-cho, Chuo-ku, Kobe City |
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+81-78-382-5885 |
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neuro@med.kobe-u.ac.jp |
Complete |
Mar. 29, 2018 |
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Dec. 12, 2018 | ||
10 | ||
Interventional |
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single arm study |
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open(masking not used) |
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no treatment control/standard of care control |
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single assignment |
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treatment purpose |
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Stable Neuromyelitis Optica patients with EDSS score less than 7.0 who wish to participate in this study |
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1. Patients with infection |
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20age old over | ||
80age old not | ||
Both |
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Neuromyelitis optica |
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Mycophenolate mofetil treatment for 1 year |
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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. |
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Decreased steroid dose |
Kobe University Clinical Research Ethical Committee | |
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo | |
+81-78-382-6669 |
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cerb@med.kobe-u.ac.jp | |
Approval | |
UMIN000031135 | |
UMIN Clinical Trials Registry (UMIN-CTR) |
none |