Phase III study with Teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis (TOPIC)

Title
Phase III study with Teriflunomide versus placebo in patients with first clinical symptom of multiple sclerosis (TOPIC)

Type of intervention
Drug

Form of MS
First symptoms of MS/clinically isolated syndrome

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.

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 90 days of the onset of suggestive symptoms

Anticipated start date

Recruitment status
Recruiting

Recruitment contacts
A/Prof Richard Macdonell, Austin Hospital, VIC. Contact Elise Heriot: 03 9496 3705

Prof John King, Royal Melbourne Hospital, VIC, Contact Josephine Baker 03 9342 7061

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

Further details
http://www.clinicaltrials.gov/ct2/show/study/NCT00622700?term=Teriflunomide&rank=9&show_locs=Y#locn

Region
TAS, VIC

Trial results

Last updated: April 2012