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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Published in:Multiple sclerosis Vol. 22; no. 13; p. 1719
Main Authors: 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
Format: Journal Article
Language:English
Published: England 01.11.2016
Subjects:
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
Online Access:Get more information
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Summary: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.
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ISSN:1477-0970
1477-0970
DOI:10.1177/1352458516667568