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Studies have found that high doses of drug-grade biotin (vitamin H, MD1003) may boost neuron and less protrusive glial cell energy and improve cell function, repair or survival.
MS-SPI study found that MD1003 improved disability outcomes in patients with multiple sclerosis within 12 months.
recently conducted a SPI2 study to assess the safety and ability of MD1003 in patients with advanced multiple sclerosis in large-scale clinical studies.
SPI2 study was conducted in 90 multiple sclerosis treatment centers in 13 countries.
patients aged 18-65, diagnosed with primary or secondary multiple sclerosis, meet the revised International Expert Group and Lublin standards, have Kurtzke functional scores of at least 2 (defined as minimum disability), and have an extended disability scale (EDSS) score of 3.5-6.5, The 25-foot walk (TW25) lasted less than 40 seconds, there was evidence of clinical disability progression, and there was no recurrence within 2 years of joining the group, and MD1003 (oral 100 mg, three times a day) or placebo was randomly accepted.
of the study was an improvement in EDSS or TW25 compared to baseline checks at 12 months and an improvement in the proportion of participants at 15 months.
642 participants were randomly assigned to receive MD1003 (n-326) or placebo (n-316).
15, 2019, after assessing the main endpoints of the last participant, the study ended with a double-blind, placebo-controlled phase with an average follow-up time of 20.1 months.
For the main results, 39 (12%) of the 326 patients in the MD1003 group, while 29 of the 316 patients in the placebo group (9%) improved at 12 months and were confirmed at 15 months (advantage ratio of 1.35).
277 (84%) of the 331 participants in the MD1003 group had treatment-emergency adverse events, while 264 (85%) of the 311 participants in the placebo group had treatment-emergency adverse events.
87 (26%) of the 331 participants in the MD1003 group and 82 (26%) of the 311 participants in the placebo group had at least one serious treatment-emergency adverse event.
1 death in the MD1003 group and no deaths in the placebo group.
study concluded that high doses and drug-grade biotin did not significantly improve the progression of disability or walking speed in patients with multiple sclerosis and were not recommended for the treatment of multiple sclerosis.
