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A Controlled, Randomized Phase Ii Clinical Trial for Efficacy and Safety Evaluation of Mannuronic Acid in Secondary Progressive Form of Multiple Sclerosis Publisher Pubmed



Najafi S1 ; Moghadam NB2 ; Saadat P3 ; Noorbakhsh SM1 ; Mohammadi AV4 ; Manouchehrinia A5 ; Hosseini M6 ; Matsuo H7 ; Mirshafiey A1
Authors
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Authors Affiliations
  1. 1. Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Neurology, Imam Hossein Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran
  3. 3. Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran
  4. 4. Shiraz Branch, Islamic Azad University, Shiraz, Iran
  5. 5. Department of Clinical Neuroscience (CNS), Karolinska Institutet, Stockholm, Sweden
  6. 6. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  7. 7. National Hospital Organization, Nagasaki Kawatana Medical Center, Nagasaki, Japan

Source: International Journal of Neuroscience Published:2022


Abstract

Background: The β-D-Mannuronic acid (M2000) as a novel immunosuppressive drug, patented (PCT/EP2017/067920), has shown positive effects in experimental model of multiple sclerosis (MS). In this study, our aim was to assess efficacy and safety outcomes in MS treated patients with mannuronic acid compared to the conventional drug. Methods: In a 6-month, randomized controlled, phase II trial, we enrolled patients who had secondary progressive multiple sclerosis (SPMS), were 21–54 years of age, with a score of 1–7 on the Expanded Disability Status Scale (EDSS), and who had at least one relapse in the previous 6 months. Patients were administered orally 1000 mg/day (two 500 mg/capsule daily) of M2000. Endpoints included changes in brain magnetic resonance imaging (MRI) measures and the EDSS score, as compared to the conventional drug (interferon beta-1a, interferon beta-1b). Results: A total of 25 (92.5%) of the M2000 treated patients and 25 conventionally treated patients completed the study. M2000 had better performance compared to the conventional drug regarding to MRI-related measurements, however, the differences between groups were not statistically significant. M2000 decreased the disability progression over the 6-month period. The EDSS score was decreased in the M2000 treated group in the sixth month versus the conventional drug (p < 0.009). Furthermore, we did not observe any short-term side effects. Conclusions: As compared with the conventional drug, mannuronic acid (M2000) improved the rate of disability progression. This clinical trial demonstrated the efficacy and safety of mannuronic acid in patients with SPMS. (Registered Clinical Trials number, IRCT2016111313739N6). © 2020 Informa UK Limited, trading as Taylor & Francis Group.
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