MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study

Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study. To confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study. Patients (n = 154) with a baseline Expanded Disability Sta...

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Vydáno v:	Multiple sclerosis Ročník 22; číslo 13; s. 1719
Hlavní autoři:	Tourbah, Ayman, Lebrun-Frenay, Christine, Edan, Gilles, Clanet, Michel, Papeix, Caroline, Vukusic, Sandra, De Sèze, Jerome, Debouverie, Marc, Gout, Olivier, Clavelou, Pierre, Defer, Gilles, Laplaud, David-Axel, Moreau, Thibault, Labauge, Pierre, Brochet, Bruno, Sedel, Frédéric, Pelletier, Jean
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England 01.11.2016
Témata:	Adult Biotin - administration & dosage Biotin - adverse effects Biotin - pharmacology Disease Progression Double-Blind Method Female Humans Male Middle Aged Multiple Sclerosis, Chronic Progressive - drug therapy Outcome Assessment, Health Care Vitamin B Complex - administration & dosage Vitamin B Complex - adverse effects Vitamin B Complex - pharmacology clinical trial Multiple sclerosis MD1003 primary progressive multiple sclerosis disability progression high-dose biotin secondary progressive multiple sclerosis
ISSN:	1477-0970, 1477-0970
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Abstract	Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study. To confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study. Patients (n = 154) with a baseline Expanded Disability Status Scale (EDSS) score of 4.5-7 and evidence of disease worsening within the previous 2 years were randomised to 12-month MD1003 (100 mg biotin) or placebo thrice daily, followed by 12-month MD1003 for all patients. The primary endpoint was the proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6-7) or a ⩾20% decrease in timed 25-foot walk time compared with the best baseline among screening or randomisation visits. A total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p = 0.005). MD1003 treatment also reduced EDSS progression and improved clinical impression of change compared with placebo. Efficacy was maintained over follow-up, and the safety profile of MD1003 was similar to that of placebo. MD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated.
AbstractList	Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study. To confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study. Patients (n = 154) with a baseline Expanded Disability Status Scale (EDSS) score of 4.5-7 and evidence of disease worsening within the previous 2 years were randomised to 12-month MD1003 (100 mg biotin) or placebo thrice daily, followed by 12-month MD1003 for all patients. The primary endpoint was the proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6-7) or a ⩾20% decrease in timed 25-foot walk time compared with the best baseline among screening or randomisation visits. A total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p = 0.005). MD1003 treatment also reduced EDSS progression and improved clinical impression of change compared with placebo. Efficacy was maintained over follow-up, and the safety profile of MD1003 was similar to that of placebo. MD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated. Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study.BACKGROUNDTreatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study.To confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study.OBJECTIVETo confirm the efficacy and safety of MD1003 in progressive MS in a double-blind, placebo-controlled study.Patients (n = 154) with a baseline Expanded Disability Status Scale (EDSS) score of 4.5-7 and evidence of disease worsening within the previous 2 years were randomised to 12-month MD1003 (100 mg biotin) or placebo thrice daily, followed by 12-month MD1003 for all patients. The primary endpoint was the proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6-7) or a ⩾20% decrease in timed 25-foot walk time compared with the best baseline among screening or randomisation visits.METHODSPatients (n = 154) with a baseline Expanded Disability Status Scale (EDSS) score of 4.5-7 and evidence of disease worsening within the previous 2 years were randomised to 12-month MD1003 (100 mg biotin) or placebo thrice daily, followed by 12-month MD1003 for all patients. The primary endpoint was the proportion of patients with disability reversal at month 9, confirmed at month 12, defined as an EDSS decrease of ⩾1 point (⩾0.5 for EDSS 6-7) or a ⩾20% decrease in timed 25-foot walk time compared with the best baseline among screening or randomisation visits.A total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p = 0.005). MD1003 treatment also reduced EDSS progression and improved clinical impression of change compared with placebo. Efficacy was maintained over follow-up, and the safety profile of MD1003 was similar to that of placebo.RESULTSA total of 13 (12.6%) MD1003-treated patients achieved the primary endpoint versus none of the placebo-treated patients (p = 0.005). MD1003 treatment also reduced EDSS progression and improved clinical impression of change compared with placebo. Efficacy was maintained over follow-up, and the safety profile of MD1003 was similar to that of placebo.MD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated.CONCLUSIONMD1003 achieves sustained reversal of MS-related disability in a subset of patients with progressive MS and is well tolerated.
Author	Tourbah, Ayman Edan, Gilles Laplaud, David-Axel Labauge, Pierre Moreau, Thibault Defer, Gilles Sedel, Frédéric De Sèze, Jerome Papeix, Caroline Vukusic, Sandra Clavelou, Pierre Debouverie, Marc Clanet, Michel Gout, Olivier Pelletier, Jean Brochet, Bruno Lebrun-Frenay, Christine
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Keywords	clinical trial Multiple sclerosis MD1003 primary progressive multiple sclerosis disability progression high-dose biotin secondary progressive multiple sclerosis
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PublicationTitle	Multiple sclerosis
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PublicationYear	2016
References	27815562 - Mult Scler. 2016 Nov;22(13):1640-1641 28337933 - Mult Scler. 2018 Feb;24(2):237-238 27899554 - Mult Scler. 2017 Apr;23(4):619-620 28337934 - Mult Scler. 2018 Feb;24(2):239 27899553 - Mult Scler. 2017 Apr;23(4):620-621
References_xml	– reference: 28337933 - Mult Scler. 2018 Feb;24(2):237-238 – reference: 28337934 - Mult Scler. 2018 Feb;24(2):239 – reference: 27899553 - Mult Scler. 2017 Apr;23(4):620-621 – reference: 27815562 - Mult Scler. 2016 Nov;22(13):1640-1641 – reference: 27899554 - Mult Scler. 2017 Apr;23(4):619-620
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Snippet	Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study. To confirm the efficacy... Treatment with MD1003 (high-dose biotin) showed promising results in progressive multiple sclerosis (MS) in a pilot open-label study.BACKGROUNDTreatment with...
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SubjectTerms	Adult Biotin - administration & dosage Biotin - adverse effects Biotin - pharmacology Disease Progression Double-Blind Method Female Humans Male Middle Aged Multiple Sclerosis, Chronic Progressive - drug therapy Outcome Assessment, Health Care Vitamin B Complex - administration & dosage Vitamin B Complex - adverse effects Vitamin B Complex - pharmacology
Title	MD1003 (high-dose biotin) for the treatment of progressive multiple sclerosis: A randomised, double-blind, placebo-controlled study
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