TOPIC

Title	An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis.
Brief Summary	This is a phase III, multi-center, placebo controlled clinical research study evaluating the safety and efficacy of an oral investigational medication for the treatment of patients with Clinically Isolated Syndrome (CIS). The study will examine whether an oral investigational medication, teriflunomide, can slow or prevent the progression of CIS to clinically definite MS. This study consists of the following phases: Screening phase (4 weeks), treatment phase (108 weeks), post-treatment phase (16 weeks). An extension study is also planned. During the course of the study, participants will be randomized to the investigational medication or placebo in a ratio of 2:1.
Purpose of the Study	Treatment
Inclusion Criteria	Recent symptoms consistent with a possible diagnosis of multiple sclerosis (MS), or Clinically Isolated Syndrome (CIS). To be eligible, patients must enroll within 60 days of the onset of suggestive symptoms.
Anticipated Start Date	Started 2008
Recruitment Status	Open to recruitment
Recruitment Contacts	Dr Mark Slee, Flinders Medical Centre, SA. Contact Marie Toubia: 08 8204 4971 Prof Simon Broadley, Gold Coast Hospital / Griffith University, QLD. Contact Susan Freeman 07 5678 0750 A/Prof Richard Macdonell, Austin Hospital, VIC. Contact Elise Heriot: 03 9496 3705 Dr Chapman, Geelong Hospital, VIC. Contact Sharryn Shavickas: 03 5226 7950 Associate Professor Bruce Taylor, Royal Hobart Hospital, Hobart Tasmania 7000 Contact Sue McGregor: 03 6220 1111
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Results