Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Teriflunomide; Placebo
Intervention description: Film-coated tablet Oral administration; Film-coated tablet Oral administration
Intervention MeSH terms: Teriflunomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 618.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: MS; Clinically Isolated Syndrome; CIS; CDMS; relapses

Summary:

      The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram
      per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of
      participants presenting with their first clinical episode consistent with multiple sclerosis
      (MS) to clinically definite multiple sclerosis (CDMS).

      The secondary objectives were:

        -  To demonstrate the effect of teriflunomide, in comparison to placebo, on:

             -  Reducing conversion to definite multiple sclerosis (DMS)

             -  Reducing annualized relapse rate (ARR)

             -  Reducing disease activity/progression as measured by Magnetic Resonance Imaging
                (MRI)

             -  Reducing accumulation of disability for at least 12 weeks as measured by the
                Expanded Disability Status Scale (EDSS)

             -  Proportion of disability-free participants as assessed by the EDSS

             -  Reducing participant-reported fatigue

        -  To evaluate the safety and tolerability of teriflunomide

        -  To evaluate the pharmacokinetics (PK) of teriflunomide

        -  Optional pharmacogenomic testing aimed at assessing the association between the main
           enzyme systems of teriflunomide metabolism and hepatic safety, and other potential
           associations between gene variations and clinical outcomes
    

Eligibility criteria:

        Inclusion Criteria:

          -  First acute or subacute, well-defined neurological event consistent with demyelination
             (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome,
             brainstem/cerebellar syndromes)

          -  Onset of MS symptoms occurring within 90 days of randomization

          -  A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter
             that are characteristic of MS

        Exclusion Criteria:

          -  Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
             systemic disease

          -  Significantly impaired bone marrow function

          -  Pregnancy or nursing

          -  Alcohol or drug abuse

          -  Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
             azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
             enrollment

          -  Any known condition or circumstance that would prevent in the investigator's opinion
             compliance or completion of the study

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.