How Can I Participate?
The first step in determining eligibility for this study is to take the pre-screening questionnaire either online or on the phone. You will be asked a series of questions related to your health and be given additional information about study site locations.
After completing the pre-screening questionnaire, and with your permission, your information will be sent to a study center in your area. Someone from the clinical research team at this center will then contact you by phone to discuss your participation in more detail. These medical research professionals will be able to answer additional questions you may have about the study, the investigational medication, and what study participation involves.
Tell Me More About Participation
The study is broken up into three periods:
1. Screening Period - 4 weeks
During this period, individuals have a series of medical tests to determine eligibility for study participation. Prior to any testing, an informed consent document must be reviewed and signed by the participant. The informed consent provides important study details that must first be read and understood by the participant. This screening period may include a complete study-related physical examination including blood work, urinalysis and other medical tests as well as a review of the person's medical history.
2. Treatment Period - 48 to 154 weeks
During the treatment period, participants in the study treatment groups take the study medication (teriflunomide or placebo) - as an oral tablet once per day in the morning.
Assessments such as Expanded Disability Status Scale (EDSS) and Fatigue Impact Scale (FIS), as well as vital signs and blood work are conducted throughout the study. The EDSS is one of the most widely used assessment tools in multiple sclerosis. The test assesses the disability associated with MS. The FIS evaluates impact of fatigue on the lives of those with MS. Both of these tests are important ways to measure whether or not teriflunomide works in treating these MS symptoms. At the end of this period, study participants enter a "post treatment" phase.
3. Post-Washout Follow Up Period - 16 weeks
During the follow-up period, staff will discuss your response to the investigational medication, do a number of lab tests, record additional information about your study treatment experience, and discuss next steps.