Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis

Summary

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.

Timeline

Start

2013-10

Primary completion

2015-12

Completion

2018-01

Outcome

Missed primary endpoint

paper The study did not meet its primary endpoint, as the mean change in the primary endpoint was nonsignificantly larger (p = 0.66) with MD1003 PMID 29808469 ↗

Publications

• Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, Lebrun-Frenay C, Labauge P, Brassat D, Toosy A, Laplaud DA, Outteryck O, Moreau T, Debouverie M, Clavelou P, Heinzlef O, De Seze J, Defer G, Sedel F, Arndt C. 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. CNS Drugs. 2018 Jul;32(7):661-672. doi: 10.1007/s40263-018-0528-2.

Drugs

Indications