Dose-finding Study of MT-1303
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
1 other identifier
interventional
415
18 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2013
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 14, 2016
September 1, 2016
1.5 years
December 2, 2012
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The total number of MRI Gd-enhanced T1-weighted lesions
Weeks 24
Study Arms (4)
MT-1303-Low
EXPERIMENTALMT-1303-Low Dose
MT-1303-Middle
EXPERIMENTALMT-1303-Middle Dose
MT-1303-High
EXPERIMENTALMT-1303-High Dose
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Research Site
Brussels, Belgium
Research Site
Sofia, Bulgaria
Research Site
Edmonton, Canada
Research Site
Zagreb, Croatia
Research Site
Prague, Czechia
Research Site
Vantaa, Finland
Research Site
Berlin, Germany
Research Site
Budapest, Hungary
Research Site
Roma, Italy
Research Site
Kaunas, Lithuania
Research Site
Katowice, Poland
Research Site
Moscow, Russia
Research Site
Belgrade, Serbia
Research Site
Madrid, Spain
Research Site
Basel, Switzerland
Research Site
Kozyatagi, Istanbul, Turkey (Türkiye)
Research Site
Kiev, Ukraine
Research Site
London, United Kingdom
Related Publications (1)
Kappos L, Arnold DL, Bar-Or A, Camm J, Derfuss T, Kieseier BC, Sprenger T, Greenough K, Ni P, Harada T. Safety and efficacy of amiselimod in relapsing multiple sclerosis (MOMENTUM): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2016 Oct;15(11):1148-59. doi: 10.1016/S1474-4422(16)30192-2. Epub 2016 Aug 16.
PMID: 27543447BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2012
First Posted
December 5, 2012
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Study Completion
October 1, 2014
Last Updated
September 14, 2016
Record last verified: 2016-09