Clinical trial NCT01742052: Dose-finding Study of MT-1303
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: relapsing-remitting multiple sclerosis
RRMS
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The total number of MRI Gd-enhanced T1-weighted lesions
timeFrame: Weeks 24
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Kozyatagi, Istanbul
country: Turkey
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.