Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet Neurology
Bruce A C CreeSPI2 investigative teams

Abstract

There is an unmet need to develop therapeutic interventions directed at the neurodegeneration that underlies progression in multiple sclerosis. High-dose, pharmaceutical-grade biotin (MD1003) might enhance neuronal and oligodendrocyte energetics, resulting in improved cell function, repair, or survival. The MS-SPI randomised, double-blind, placebo-controlled study found that MD1003 improved disability outcomes over 12 months in patients with progressive multiple sclerosis. The SPI2 study was designed to assess the safety and efficacy of MD1003 in progressive forms of multiple sclerosis in a larger, more representative patient cohort. SPI2 was a randomised, double-blind, parallel-group, placebo-controlled trial done at 90 academic and community multiple sclerosis clinics across 13 countries. Patients were aged 18-65 years, had a diagnosis of primary or secondary progressive multiple sclerosis fulfilling the revised International Panel criteria and Lublin criteria, a Kurtzke pyramidal functional subscore of at least 2 (defined as minimal disability), an expanded disability status scale (EDSS) score of 3·5-6·5, a timed 25-foot walk (TW25) of less than 40 s, evidence of clinical disability progression, and no relapses in the 2 year...Continue Reading

Associated Clinical Trials

References

Feb 24, 2009·Lancet Neurology·Bruce D Trapp, Peter K Stys
Oct 7, 2011·Neurology·M S FreedmanUNKNOWN MAESTRO-01 Investigators
Jun 21, 2012·Nature Reviews. Neuroscience·Peter K StysJeroen J G Geurts
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Citations

Nov 24, 2020·Lancet Neurology·Jeremias Motte, Ralf Gold
Feb 24, 2021·JAMA : the Journal of the American Medical Association·Marisa P McGinleyAlexander D Rae-Grant
Mar 27, 2021·Multiple Sclerosis : Clinical and Laboratory Research·Bruce Ac CreeLudwig Kappos
May 4, 2021·Frontiers in Cellular Neuroscience·Myriam CayrePascale Durbec
May 11, 2021·Autoimmunity Reviews·Giuseppe MurdacaSebastiano Gangemi
Jun 25, 2021·Frontiers in Neurology·Jameson P HollomanGregory F Wu
May 18, 2021·Paediatric Drugs·Cristina Fernandez-CarbonellLauren B Krupp
Jul 12, 2021·Multiple Sclerosis and Related Disorders·Bardia NourbakhshAndrew J Solomon
Aug 1, 2021·Multiple Sclerosis and Related Disorders·Adrian I Espiritu, Patricia Pauline M Remalante-Rayco
Aug 11, 2021·Annals of Laboratory Medicine·Khaldoun GhazalMarie-Liesse Piketty
Sep 6, 2021·Journal of Neurology·Hesham AbboudUNKNOWN On-behalf of the Guthy-Jackson Foundation NMO International Clinical Consortium

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