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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002639-27-GB

Enrollment

400

Registered

2012-11-20

Start date

2013-03-11

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 16.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: MT-1303 Product Code: MT-1303 Pharmaceutical Form: Capsule INN or Proposed INN: MT-1303 Current Sponsor code: MT-1303

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 • To evaluate the pharmacodynamics of MT-1303 in subjects with RRMS ; Primary end point(s): Safety Assessments • Adverse events (AEs) • Vital signs • 12-lead electrocardiogram (ECG) • 3-lead Holter ECG monitoring • Routine safety laboratory assessments • Physical examination • 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	—

Measure

Time frame

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 • To evaluate the pharmacodynamics of MT-1303 in subjects with RRMS ; Primary end point(s): Safety Assessments • Adverse events (AEs) • Vital signs • 12-lead electrocardiogram (ECG) • 3-lead Holter ECG monitoring • Routine safety laboratory assessments • Physical examination • 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

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Secondary

Measure	Time frame
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 end point(s): Clinical Efficacy Endpoints: • Annualised Relapse Rate (ARR) • Time to first confirmed relapse • Proportion of subjects who remain relapse-free at End of Treatment (EOT) • Change from baseline in total Expanded Disability Status Scale (EDSS) score at EOT • Change from baseline in total Multiple Sclerosis Functional Composite (MSFC) score at EOT MRI Endpoints: • Number of MRI Gd-enhanced T1-weighted lesions • Number and volume of new or enlarged T2-weighted lesions • Change and percent change in brain volume at EOT • Magnetisation Transfer Ratio (MTR) related endpoints will be explored. Details to be specified in the Statistical Analysis Plan (SAP) (selected centres only) Pharmacodynamic Endpoints: • Lymphocyte counts • Lymphocyte subsets (selected centres only) Subject-reported Endpoints: • Change from baseline in MSQOL-54 at EOT.	—

Measure

Time frame

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 end point(s): Clinical Efficacy Endpoints: • Annualised Relapse Rate (ARR) • Time to first confirmed relapse • Proportion of subjects who remain relapse-free at End of Treatment (EOT) • Change from baseline in total Expanded Disability Status Scale (EDSS) score at EOT • Change from baseline in total Multiple Sclerosis Functional Composite (MSFC) score at EOT MRI Endpoints: • Number of MRI Gd-enhanced T1-weighted lesions • Number and volume of new or enlarged T2-weighted lesions • Change and percent change in brain volume at EOT • Magnetisation Transfer Ratio (MTR) related endpoints will be explored. Details to be specified in the Statistical Analysis Plan (SAP) (selected centres only) Pharmacodynamic Endpoints: • Lymphocyte counts • Lymphocyte subsets (selected centres only) Subject-reported Endpoints: • Change from baseline in MSQOL-54 at EOT.

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Countries

Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Russian Federation, Serbia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom

Contacts

Public ContactClinical Project Manager

Mitsubishi Pharma Europe Ltd (MPE)

KGreenough@m-pharma.co.uk00442070655000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026