NCT01742052

Dose-finding Study of MT-1303

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of the study are: * To evaluate the effects of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with relapsing-remitting multiple sclerosis (RRMS) on MRI parameters * To evaluate the safety and tolerability of three oral doses of MT-1303 compared to placebo given for a period of 24 weeks in subjects with RRMS.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	MT-1303-Low
DRUG	MT-1303-Middle
DRUG	MT-1303-High
DRUG	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2012-12-05
• Last updated: 2016-09-14

Locations

18 sites across 18 countries: Belgium, Bulgaria, Canada, Croatia, Czechia, Finland, Germany, Hungary, Italy, Lithuania, Poland, Russia, Serbia, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom