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

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT00622700

Run by

Sanofi

People needed

618

Starts

2008-02-01

Expected to finish

2016-02-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 8954 — Phoenix, Arizona, United States
• Investigational Site Number 8946 — Phoenix, Arizona, United States
• Investigational Site Number 8962 — Fort Collins, Colorado, United States
• Investigational Site Number 8920 — Maitland, Florida, United States
• Investigational Site Number 8953 — St. Petersburg, Florida, United States
• Investigational Site Number 8914 — Fort Wayne, Indiana, United States
• Investigational Site Number 8940 — Indianapolis, Indiana, United States
• Investigational Site Number 8922 — Shreveport, Louisiana, United States
• Investigational Site Number 8955 — Grand Rapids, Michigan, United States
• Investigational Site Number 8949 — Traverse City, Michigan, United States
• Investigational Site Number 8937 — St Louis, Missouri, United States
• Investigational Site Number 8951 — Albuquerque, New Mexico, United States
• Investigational Site Number 8925 — New York, New York, United States
• Investigational Site Number 8941 — Charlotte, North Carolina, United States
• Investigational Site Number 8924 — Dayton, Ohio, United States
• Investigational Site Number 8905 — Round Rock, Tennessee, United States
• Investigational Site Number 8930 — Burlington, Vermont, United States
• Investigational Site Number 8963 — Seattle, Washington, United States
• Investigational Site Number 1405 — Geelong, Australia
• Investigational Site Number 1404 — Heidelberg, Australia
• Investigational Site Number 1407 — Hobart, Australia
• Investigational Site Number 1401 — Parkville, Australia
• Investigational Site Number 4004 — Innsbruck, Austria
• Investigational Site Number 4005 — Linz, Austria
• Investigational Site Number 8965 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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