Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Teriflunomide

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.