MT-1303-E05 extension study; Safety & efficacy of MT-1303 in RRMS
Research type
Research Study
Full title
A phase II, multicentre study to evaluate the long-term safety and efficacy of MT-1303 in subjects with relapsing-remitting multiple sclerosis who have completed the MT-1303-E04 study
IRAS ID
117170
Contact name
Benjamin Turner
Sponsor organisation
Mitsubishi Tanabe Pharma Corporation
Eudract number
2012-002639-27
ISRCTN Number
ISRCTN
Research summary
International, multicentre, parallel group, 2-part study to evaluate the safety and efficacy of MT-1303 administered orally once daily for 18 months in subjects with relapsing-remitting multiple sclerosis (RRMS).The MT-1303-E05 is an extension study of the MT-1303-E04 study.Up to 400, male or female subjects, aged 18-60 years of age, who have completed MT-1303-E04 study and comply with the eligibility criteria may enter the MT-1303-E05 study. The actual number will depend on the number of subjects who complete the 24-week Treatment Period in the MT-1303-E04 study.The study consists of 2 Parts:Part 1:Eligible subjects who were randomly assigned to one of three oral doses of MT-1303 in the MT-1303-E04 study will continue to receive the same dose of MT-1303.Eligible subjects who were randomly assigned to placebo in the MT-1303-E04 study will be randomised to receive treatment with one of three oral doses of MT-1303 (0.1mg, 0.2mg or 0.4mg) in a 1:1:1 ratio.Part 2:Following analysis and reporting of MT-1303-E04 and determination of the effective dose(s) of once daily MT-1303, all ongoing subjects with a minimum of 12 weeks left in the Treatment Period for the MT-1303-E05 study will receive treatment with the effective dose(s) of MT-1303 for the remainder of the 18-month Treatment Period.Following completion of treatment, all subjects will enter a 12-week Safety Follow-up Period.
REC name
London - Central Research Ethics Committee
REC reference
13/LO/0195
Date of REC Opinion
11 Mar 2013
REC opinion
Favourable Opinion