Clinical Trial Details

Overview

Research Study Summary

Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (OPTIMUM)

Purpose

International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

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CW ID: 207334
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 55 Years
Overall Status
Recruiting
Lead Sponsor
Actelion
Duration
108 Weeks
Facility Type
Out-Patient

Eligibility

Inclusion Criteria:

  • Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010 with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses)
  • Subjects must have active disease evidenced by one or more MS attacks within the period of 12 to 1 months prior to randomization, or by two or more MS attacks within the 24 to 1 months prior to randomization, or with one or more Gd+ lesion(s) of the brain on an MRI performed within 6 months prior to randomization
  • Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with MS disease modifying therapy

Exclusion Criteria:

  • Subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study
  • Subjects with contraindications to MRI or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study

Contact

Laurie Pearsall
University of South Florida- Morsani Center for Advanced Healthcare
13330 Laurel Dr.
Tampa, FL 33613
Phone: 813-974-9424

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