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)

  • STATUS
    Recruiting
  • sponsor
    Actelion
Updated on 8 November 2020

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)

Description

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

Details
Clinical Study IdentifierTX140624
SponsorActelion
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 55 yrs?
Gender: Male or Female
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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