Safety and Efficacy of 3 doses of MT-1303 over 24 weeks in RRMS

• Research type

  Research Study

• Full title

  A phase II, multicentre, randomised, double-blind, parallel group, placebo-controlled, dose-finding study to evaluate the safety and efficacy of three different oral doses of MT-1303 administered for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis

• IRAS ID

  111375

• Contact name

  Benjamin Turner

• Sponsor organisation

  Mitsubishi Tanabe Pharma Corporation

• Eudract number

  2012-002470-31

• ISRCTN Number

  not issued

• Research summary

  International, multicentre, double-blind, parallel group, placebo-controlled, randomised, dose-finding study to evaluate the safety and efficacy of three dose levels of MT-1303 administered orally once daily for a period of 24 weeks in patients with relapsing-remitting multiple sclerosis (RRMS). Eligible patients will be randomly assigned to receive one of three oral doses of MT-1303 (0.1, 0.2 or 0.4mg) or matching placebo in a 1:1:1:1 ratio. The study consists of a Screening Period of up to 6 weeks, a 24-week Treatment Period and a 12-week Safety Follow-up Period. Subjects who complete the 24-week placebo-controlled Treatment Period will have the option of entering an 18-month extension study (MT-1303-E05)directly after the Treatment Period.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/1679

• Date of REC Opinion

  29 Oct 2012

• REC opinion

  Favourable Opinion