Dose-finding Study of MT-1303

Sponsor

Mitsubishi Tanabe Pharma Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01742052

Collaborator

(none)

415

Enrollment

Locations

Arms

Duration (Months)

23.1

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing-remitting Multiple Sclerosis	Drug: MT-1303-Low Drug: MT-1303-Middle Drug: MT-1303-High Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

415 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT-1303-Low MT-1303-Low Dose	Drug: MT-1303-Low
Experimental: MT-1303-Middle MT-1303-Middle Dose	Drug: MT-1303-Middle
Experimental: MT-1303-High MT-1303-High Dose	Drug: MT-1303-High
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

The total number of MRI Gd-enhanced T1-weighted lesions [Weeks 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Brussels	Belgium
2	Research Site	Sofia	Bulgaria
3	Research Site	Edmonton	Canada
4	Research Site	Zagreb	Croatia
5	Research Site	Praha	Czech Republic
6	Research Site	Vantaa	Finland
7	Research Site	Berlin	Germany
8	Research Site	Budapest	Hungary
9	Research Site	Roma	Italy
10	Research Site	Kaunas	Lithuania
11	Research Site	Katowice	Poland
12	Research Site	Moscow	Russian Federation
13	Research Site	Belgrade	Serbia
14	Research Site	Madrid	Spain
15	Research Site	Basel	Switzerland
16	Research Site	Kozyatagi, Istanbul	Turkey
17	Research Site	Kiev	Ukraine
18	Research Site	London	United Kingdom