Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)

Summary

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.

Timeline

Start

2016-12

Primary completion

2019-11-15

Completion

2020-04-23

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision for business purposes”

paper This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis PMID 33222767 ↗

release “the second pivotal Phase III trial (SPI2) of its investigational product MD1003 has not met its primary and secondary endpoints” medday-pharma.com ↗

Publications

• Cree BAC, Cutter G, Wolinsky JS, Freedman MS, Comi G, Giovannoni G, Hartung HP, Arnold D, Kuhle J, Block V, Munschauer FE, Sedel F, Lublin FD; SPI2 investigative teams. Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):988-997. doi: 10.1016/S1474-4422(20)30347-1. Epub 2020 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Biotin	Small molecule	100 mg	—

Indications