MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, ... View Full Text


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Article Info

DATE

2018-05-28

AUTHORS

Ayman Tourbah, Olivier Gout, Alain Vighetto, Véronique Deburghgraeve, Jean Pelletier, Caroline Papeix, Christine Lebrun-Frenay, Pierre Labauge, David Brassat, Ahmed Toosy, David-Axel Laplaud, Olivier Outteryck, Thibault Moreau, Marc Debouverie, Pierre Clavelou, Olivier Heinzlef, Jérôme De Sèze, Gilles Defer, Frédéric Sedel, Carl Arndt

ABSTRACT

BACKGROUND: Chronic visual loss is a disabling feature in patients with multiple sclerosis (MS). It was recently shown that MD1003 (high-dose pharmaceutical-grade biotin or hdPB) may improve disability in patients with progressive MS. OBJECTIVE: The aim of this study was to evaluate whether MD1003 improves vision compared with placebo in MS patients with chronic visual loss. METHODS: The MS-ON was a 6-month, randomized, double-blind, placebo-controlled study with a 6-month open-label extension phase. Adult patients with MS-related chronic visual loss of at least one eye [visual acuity (VA) below 0.5 decimal chart] were randomized 2:1 to oral MD1003 300 mg/day or placebo. The selected eye had to show worsening of VA within the past 3 years following either acute optic neuritis (AON) or slowly progressive optic neuropathy (PON). The primary endpoint was the mean change from baseline to month 6 in VA measured in logarithm of the minimum angle of resolution (logMAR) at 100% contrast of the selected eye. Visually evoked potentials, visual field, retinal nerve fiber layer (RNFL) thickness, and health outcomes were also assessed. RESULTS: Ninety-three patients received MD1003 (n = 65) or placebo (n = 28). The study did not meet its primary endpoint, as the mean change in the primary endpoint was nonsignificantly larger (p = 0.66) with MD1003 (- 0.061 logMAR, + 3.1 letters) than with placebo (- 0.036 logMAR, + 1.8 letters). Pre-planned subgroup analyses showed that 100% contrast VA improved by a mean of + 2.8 letters (- 0.058 logMAR) with MD1003 and worsened by - 1.5 letters (+ 0.029 logMAR) with placebo (p = 0.45) in the subgroup of patients with PON. MD1003-treated patients also had nonsignificant improvement in logMAR at 5% contrast and in RNFL thickness and health outcome scores when compared with placebo-treated patients. There was no superiority of MD1003 vs placebo in patients with AON. The safety profile of MD1003 was similar to that of placebo. CONCLUSIONS: MD1003 did not significantly improve VA compared with placebo in patients with MS experiencing chronic visual loss. An interesting trend favoring MD1003 was observed in the subgroup of patients with PON. Treatment was overall well tolerated. TRIAL REGISTRATION: EudraCT identifier 2013-002112-27. ClinicalTrials.gov Identifier: NCT02220244 FUNDING: MedDay Pharmaceuticals. More... »

PAGES

661-672

References to SciGraph publications

  • 2009-10-14. ISCEV standard for clinical visual evoked potentials (2009 update) in DOCUMENTA OPHTHALMOLOGICA
  • 1982-06. Subclinical visual field defects in multiple sclerosis in JOURNAL OF NEUROLOGY
  • 2012-06-20. Will the real multiple sclerosis please stand up? in NATURE REVIEWS NEUROSCIENCE
  • 2012-08-07. Structure and function of biotin-dependent carboxylases in CELLULAR AND MOLECULAR LIFE SCIENCES
  • Journal

    TITLE

    CNS Drugs

    ISSUE

    7

    VOLUME

    32

    Author Affiliations

    Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s40263-018-0528-2

    DOI

    http://dx.doi.org/10.1007/s40263-018-0528-2

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1104265487

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29808469


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        "description": "BACKGROUND: Chronic visual loss is a disabling feature in patients with multiple sclerosis (MS). It was recently shown that MD1003 (high-dose pharmaceutical-grade biotin or hdPB) may improve disability in patients with progressive MS.\nOBJECTIVE: The aim of this study was to evaluate whether MD1003 improves vision compared with placebo in MS patients with chronic visual loss.\nMETHODS: The MS-ON was a 6-month, randomized, double-blind, placebo-controlled study with a 6-month open-label extension phase. Adult patients with MS-related chronic visual loss of at least one eye [visual acuity (VA) below 0.5 decimal chart] were randomized 2:1 to oral MD1003 300\u00a0mg/day or placebo. The selected eye had to show worsening of VA within the past 3\u00a0years following either acute optic neuritis (AON) or slowly progressive optic neuropathy (PON). The primary endpoint was the mean change from baseline to month 6 in VA measured in logarithm of the minimum angle of resolution (logMAR) at 100% contrast of the selected eye. Visually evoked potentials, visual field, retinal nerve fiber layer (RNFL) thickness, and health outcomes were also assessed.\nRESULTS: Ninety-three patients received MD1003 (n\u00a0=\u00a065) or placebo (n\u00a0=\u00a028). The study did not meet its primary endpoint, as the mean change in the primary endpoint was nonsignificantly larger (p\u00a0=\u00a00.66) with MD1003 (- 0.061 logMAR, + 3.1 letters) than with placebo (- 0.036 logMAR, + 1.8 letters). Pre-planned subgroup analyses showed that 100% contrast VA improved by a mean of + 2.8 letters (- 0.058 logMAR) with MD1003 and worsened by - 1.5 letters (+ 0.029 logMAR) with placebo (p\u00a0=\u00a00.45) in the subgroup of patients with PON. MD1003-treated patients also had nonsignificant improvement in logMAR at 5% contrast and in RNFL thickness and health outcome scores when compared with placebo-treated patients. There was no superiority of MD1003 vs placebo in patients with AON. The safety profile of MD1003 was similar to that of placebo.\nCONCLUSIONS: MD1003 did not significantly improve VA compared with placebo in patients with MS experiencing chronic visual loss. An interesting trend favoring MD1003 was observed in the subgroup of patients with PON. Treatment was overall well tolerated.\nTRIAL REGISTRATION: EudraCT identifier 2013-002112-27. ClinicalTrials.gov Identifier: NCT02220244 FUNDING: MedDay Pharmaceuticals.", 
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