MD1003 in progressive multiple sclerosis
Research type
Research Study
Full title
Effect of MD1003 in progressive multiple sclerosis: a randomised double blind placebo controlled study
IRAS ID
214075
Contact name
Michael Dudley
Contact email
Sponsor organisation
MEDDAY PHARMACEUTICALS SA
Eudract number
2016-000700-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 0 days
Research summary
Multiple sclerosis (known as MS) is a nervous system disease that affects the brain and spinal cord. MS damages the myelin sheath which is the material that surrounds and protects nerve cells. Nerve cells transmit messages throughout the body and the damage done by MS slows down or blocks these messages, leading to the symptoms of the disease. The symptoms of MS are referred to as neurological dysfunction and can include muscle weakness, problems with vision, problems with coordination (movement), and problems with sensation (feeling).
The disease can be divided into either relapsing-remitting MS (RRMS) or as progressive MS. RRMS is characterised by short and sudden periods of neurological dysfunction (named relapses), followed by variable recovery and periods of stability. In contrast, progressive MS is defined by a progressive worsening of neurological function either from the beginning of the disease (primary progressive MS) or after a first phase of RRMS (secondary progressive MS).
The purpose of this clinical research study is to evaluate MD1003 (high-dose biotin) in participants with progressive MS. The developers of MD1003 want to see how well the drug works and what side effects are seen. Biotin is a vitamin that is normally present in food and is needed for energy production in cells. It could also help with repair of the myelin sheath. The study is ‘placebo-controlled’ which means some patients will be given a dummy drug to act as a comparison. Participants will be randomised (like flipping a coin) to receive either MD1003 or a tablet that looks the same but does not contain MD1003.
The Sponsor of the study is MedDay Pharmaceuticals SA. Initially, around 300 participants are expected to be involved in the trial at approximately 55 hospitals in the UK, elsewhere in Europe, and in North America.REC name
London - South East Research Ethics Committee
REC reference
17/LO/0169
Date of REC Opinion
13 Apr 2017
REC opinion
Further Information Favourable Opinion