- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01742052
Dose-finding Study of MT-1303
September 12, 2016 updated by: Mitsubishi Tanabe Pharma Corporation
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
415
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium
- Research Site
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Sofia, Bulgaria
- Research Site
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Edmonton, Canada
- Research Site
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Zagreb, Croatia
- Research Site
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Praha, Czech Republic
- Research Site
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Vantaa, Finland
- Research Site
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Berlin, Germany
- Research Site
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Budapest, Hungary
- Research Site
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Roma, Italy
- Research Site
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Kaunas, Lithuania
- Research Site
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Katowice, Poland
- Research Site
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Moscow, Russian Federation
- Research Site
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Belgrade, Serbia
- Research Site
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Madrid, Spain
- Research Site
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Basel, Switzerland
- Research Site
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Kozyatagi, Istanbul, Turkey
- Research Site
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Kiev, Ukraine
- Research Site
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London, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- RRMS as defined by the revised McDonald criteria
Evidence of recent MS activity defined as either:
- at least one documented relapse in the previous 12 months, OR
- a positive gadolinium (Gd)-enhanced MRI scan within 3 months prior to screening, OR
- at least two documented relapses in the previous 24 months with a positive Gd-enhanced MRI scan within the previous 12 months
- Expanded Disability Status Score (EDSS) score ≥0.0 and ≤5.5 points.
Exclusion Criteria:
- Primary progressive, secondary progressive or progressive relapsing MS at screening
- Disease duration >15 years combined with an EDSS score ≤2.0
- Relapse of MS during the Screening Period
- History or known presence of other neurological disorders likely to render the subject unsuitable for the study
- History of any of a list of pre-defined cardiovascular diseases
- History or known presence of any significant central nervous system, infectious, metabolic, oncological, ophthalmological or respiratory system disease or illness likely to render the subject unsuitable for the study
- Previous exposure to any sphingosine 1-phosphate receptor modulator
- Receipt of a live vaccine or systemic corticosteroid use within 28 days prior to randomisation
- Previous treatment with beta-interferons or glatiramer acetate within 14 days prior to randomisation
- Previous treatment with intravenous immunoglobulin, plasmapheresis, certain immunosuppressants, lymphocyte-depleting therapy, total body irradiation or bone marrow transplantation
- Need, or likely need for, treatment with Class I or III anti-arrhythmic drugs or with heart-rate-lowering beta-blockers or calcium-channel blockers, or with any other drugs which can reduce the heart rate
- Evidence of significant anaemia, thrombocytopenia, leucopoenia or lymphocytopenia, renal or hepatic impairment
- Clinically significant electrocardiogram (ECG) findings.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Experimental: MT-1303-Low
MT-1303-Low Dose
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Experimental: MT-1303-Middle
MT-1303-Middle Dose
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Experimental: MT-1303-High
MT-1303-High Dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The total number of MRI Gd-enhanced T1-weighted lesions
Time Frame: Weeks 24
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Weeks 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
December 2, 2012
First Submitted That Met QC Criteria
December 2, 2012
First Posted (Estimate)
December 5, 2012
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-1303-E04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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