A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.

Phase 1

• Conditions: Relapsing-remitting multiple sclerosis (RRMS); MedDRA version: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002639-27-BG
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-13
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Completion of the 24-week Treatment Period in MT-1303-E04 as per protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Permanent discontinuation of study medication prior to the End of Treatment (EOT) Visit in MT-1303-E04
2. Newly diagnosed diabetes mellitus during MT-1303-E04

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified