Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT00622700

CompletedPhase 3

Sponsor: Sanofi

Conditions: Multiple Sclerosis

Interventions: Teriflunomide, Placebo

Countries: United States, Australia, Austria, Bulgaria, Canada, Chile, Czechia, Denmark

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (131)
  • Cullman, Alabama, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Fort Collins, Colorado, United States
  • Maitland, Florida, United States
  • St. Petersburg, Florida, United States
  • Fort Wayne, Indiana, United States
  • Indianapolis, Indiana, United States
  • Shreveport, Louisiana, United States
  • Grand Rapids, Michigan, United States
  • Traverse City, Michigan, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Dayton, Ohio, United States
  • Round Rock, Tennessee, United States
  • Burlington, Vermont, United States
  • Seattle, Washington, United States
  • Geelong, Australia
  • Heidelberg, Australia
  • Hobart, Australia
  • Parkville, Australia
  • Innsbruck, Austria
  • Linz, Austria
  • Vienna, Austria
  • Pleven, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • + 101 more on CT.gov