Dose-finding Study of MT-1303

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742052
• Other study ID #: MT-1303-E04
• Status: Completed
• Phase: Phase 2
• First received: December 2, 2012
• Last updated: September 12, 2016
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: September 2016
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: October 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• MT-1303-Low

• MT-1303-Middle

• MT-1303-High

• Placebo

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Bulgaria	Research Site	Sofia
Canada	Research Site	Edmonton
Croatia	Research Site	Zagreb
Czech Republic	Research Site	Praha
Finland	Research Site	Vantaa
Germany	Research Site	Berlin
Hungary	Research Site	Budapest
Italy	Research Site	Roma
Lithuania	Research Site	Kaunas
Poland	Research Site	Katowice
Russian Federation	Research Site	Moscow
Serbia	Research Site	Belgrade
Spain	Research Site	Madrid
Switzerland	Research Site	Basel
Turkey	Research Site	Kozyatagi, Istanbul
Ukraine	Research Site	Kiev
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Canada,  Croatia,  Czech Republic,  Finland,  Germany,  Hungary,  Italy,  Lithuania,  Poland,  Russian Federation,  Serbia,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

References & 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 Aug 16. pii: S1474-4422(16)30192-2. doi: 10.1016/S1474-4422(16)30192-2. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of MRI Gd-enhanced T1-weighted lesions		Weeks 24	No