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

• Register: EUCTR
• Last refreshed on: 16 January 2017
• Main ID: EUCTR2012-002639-27-BG
• Date of registration: 13/03/2013
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation (MTPC)
• Public title: A study to assess long-term safety and effectiveness of MT-1303 in subjects who completed the MT-1303-E04 study.
• Scientific title: 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
• Date of first enrolment: 30/04/2013
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002639-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: Single blind: no Double blind: Parallel group: Cross over: no Other: yes Other trial design description: This study is a parallel group 2 part study. Part 1 is double-blind; Part 2 is open-label If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Clinical Project Manager
• Affiliation: Mitsubishi Pharma Europe Ltd (MPE)

• Name: Clinical Project Manager
• Affiliation: Mitsubishi Pharma Europe Ltd (MPE)

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 18.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.1-

Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.2-

Product Name: MT-1303
Product Code: MT-1303
Pharmaceutical Form: Capsule
INN or Proposed INN: MT-1303
Current Sponsor code: MT-1303
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.4-

Primary Outcome(s)

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 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)

Main Objective: To evaluate the long-term safety and tolerability of MT-1303 in subjects with RRMS

Secondary Outcome(s)

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.

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 ID(s)

MT-1303-E05

2012-002639-27-GB

Source(s) of Monetary Support

Mitsubishi Tanabe Pharma Corporation (MTPC)