Biotin study

Trialling the effect and safety of MD1003 (high dose Biotin) in participants with progressive MS.

Condition(s)

Multiple sclerosis

Project type

Clinical drug trial

About the project

Biotin is a vitamin that is normally present in food and is needed for energy production in cells. It could also help with myelin repair. In previous studies, it was shown that the use of biotin at high doses (300 mg/day, which corresponds to 10,000 times the amount usually present in the average diet) may slow the progression of clinical signs in participants with progressive MS.

The study involves 11 visits to the Anne Rowling Clinic over 28 months. The study visits will include a physical examination, blood test, questionnaires and ECG (heart tracing). Participants will get a 50/50 chance of being on the investigational drug or placebo. Part way through the trial, all participants will have the opportunity to take the investigational drug.

Funder(s)

The sponsor of this study is MedDay Pharmaceuticals SA.

Publication(s)

Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial.

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.

2020 Oct 23 in

Pubmed

DOI: 10.1016/S1474-4422(20)30347-1

Status

Completed

Contact

Dawn Lyle, Research Project Coordinator

Dawn.Lyle@nhslothian.scot.nhs.uk

0131 465-9517

Eligibility criteria

People with progressive MS who are aged 18-65 may be eligible. Other criteria apply.