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: 19.0Level: 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-PL

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of MT-1303 in subjects with RRMS;Secondary Objective: • To evaluate the long-term effects of MT-1303 on magnetic resonance imaging (MRI) parameters, clinical outcomes and health-related quality of life in subjects with RRMS<br>• To evaluate the pharmacodynamics of MT-1303 in subjects with RRMS;Primary end point(s): Safety Assessments<br>• Adverse events (AEs)<br>• Vital signs<br>• 12-lead electrocardiogram (ECG)<br>• 3-lead Holter ECG monitoring<br>• Routine safety laboratory assessments<br>• Physical examination<br>• Optical coherence tomography (OCT);Timepoint(s) of evaluation of this end point: Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details

Secondary Outcome Measures