Effect of MD1003 in multiple sclerosis
Research type
Research Study
Full title
Effect of MD1003 in chronic visual loss related to optic neuritis in multiple sclerosis: a pivotal randomized double masked placebo controlled study
IRAS ID
157303
Contact name
Guillaume BRION
Contact email
Sponsor organisation
Medday Pharmaceuticals
Eudract number
2013-002112-27
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
The aim of this study is to assess the efficacy and safety of high dose biotin in patients affected with multiple sclerosis and presenting with partial visual loss after optic neuritis.
Biotin is a vitamin naturally found in the diet. It plays a key role in cell energy metabolism processes. It is also believed to promote myelin repair. The normal daily intake of biotin is about 35 to 70 µg/day. In a study involving a small group of patients, high doses of biotin (between 100 and 300 mg/day: 3000 times the amount physiologically ingested through the diet) led to the improvement of multiple sclerosis clinical signs, and particularly of visual acuity and visual fields in patients with optic neuritis-induced impairment.
These high doses have already been used in humans for the treatment of orphan diseases and do not have any known side effects.This study will last a total of 12 months. During the first 6 month period, enrolled patients will be randomly allocated to one of two groups: the first group of 35 patients will receive a biotin placebo (a placebo is a substance that has no known pharmacological effect) and the second group of 70 patients will receive 300 mg of biotin a day. At the end of this 6 month period, all the patients (105 in total) will receive 300 mg of biotin a day for a further 6 months.
This study requires 6 hospital appointments and 2 safety telephone calls. Appointments will be scheduled with the neurologist. Patients will come to the hospital for ophthalmology assessment. The first two appointments (including screening visit with signature of the consent form) will be scheduled at one-month intervals and all the others will take place at three-month intervals(i.e.; M3,M6,M9 and M12).
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/1107
Date of REC Opinion
28 Aug 2014
REC opinion
Further Information Favourable Opinion