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MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study

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اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • Contributors:
      Hôpital universitaire Robert Debré Reims (CHU Reims); Laboratoire de Psychopathologie et Neuropsychologie (LPN); Université Paris 8 Vincennes-Saint-Denis (UP8); Fondation Ophtalmologique Adolphe de Rothschild Paris; Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); Hospices Civils de Lyon (HCL); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre de résonance magnétique biologique et médicale (CRMBM); Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS); Institut du Cerveau = Paris Brain Institute (ICM); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS); COMUE Université Côte d'Azur (2015-2019) (COMUE UCA); CHU Montpellier = Montpellier University Hospital; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Centre de Physiopathologie Toulouse Purpan (CPTP); Université Toulouse III - Paul Sabatier (UT3); Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS); University College of London London (UCL); Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Immunoregulation And Immunointervention in Transplantation and Autoimmunity (Team 4 - U1064 Inserm - CRTI); Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE); Université de Nantes (UN)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE); Université de Nantes (UN)-Université de Nantes (UN); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Lille Inflammation Research International Center - U 995 (LIRIC); Institut Pasteur de Lille; Pasteur Network (Réseau International des Instituts Pasteur)-Pasteur Network (Réseau International des Instituts Pasteur)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); CHU Dijon; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon); Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy); CHU Clermont-Ferrand; CHI Poissy-Saint-Germain; CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P)); Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg; Les Hôpitaux Universitaires de Strasbourg (HUS)-Les Hôpitaux Universitaires de Strasbourg (HUS)-Hôpital de Hautepierre Strasbourg; CHU Caen; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN); MedDay Pharmaceuticals; MedDay Pharmaceuticals.
    • بيانات النشر:
      HAL CCSD
      Springer Verlag
    • الموضوع:
      2018
    • Collection:
      LillOA (HAL Lille Open Archive, Université de Lille)
    • نبذة مختصرة :
      International audience ; 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 ...
    • الرقم المعرف:
      10.1007/s40263-018-0528-2
    • الدخول الالكتروني :
      https://inserm.hal.science/inserm-02157957
      https://inserm.hal.science/inserm-02157957v1/document
      https://inserm.hal.science/inserm-02157957v1/file/40263_2018_Article_528.pdf
      https://doi.org/10.1007/s40263-018-0528-2
    • Rights:
      info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.206674