Tower

Title
 A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing 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 relapsing multiple sclerosis (RMS). The study will examine the effect of oral investigational medication on frequency of MS relapses in patients with RMS. During the course of the study, participants will be randomized to the investigational medication or placebo in a ratio of 2:1. The treatment duration is 48 weeks for the last patient recruited. The treatment period will have a fixed end for all patients who will have the last treatment visit after the EOT (48 weeks) for the last patient randomized. For those patients who complete the treatment period, a long term extension study will be proposed.
Purpose of the Study
 Treatment
Inclusion Criteria

  • Patients with relapsing forms of multiple sclerosis meeting McDonald's criteria for MS diagnosis at time of screening visit, and EDSS score =5.5 at screening visit.
  • At least one relapse in the 12 months preceding randomization, or at least 2 relapses in the 24 months preceding the randomization visit
Anticipated Start Date
 Started 2008
Recruitment Status
 Open to recruitment

  • Approximately 1110 patients to be recruited in total
Recruitment Contacts

Dr Michael Barnett, Brain and Mind Research Institute, Camperdown,  NSW. Contact Linda Pallot 02 9351 0704 or Marinda Taha 02 9351 0667

Dr Lechner-Scott, John Hunter Hospital, NSW. Contact Nicole Lingard: 02 4985 5883

Dr Mark Paine, St Vincents Hospital, VIC. Contact Louise Rath: 03 9288 3557

Dr Karyn Boundy, The Queen Elizabeth Hospital, Woodville South, SA 5011 Contact Peter Cheung: 08 8222 8161

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

Dr Cameron Shaw, Geelong Hospital, VIC. Contact Sharryn Savickas: 03 5246 5153

Dr Mark Slee, Flinders Medical Centre, SA. Contact Marie Toubia: 08 8204 4971

Prof Roy Beran, Strategic Health Evaluators, Chatswood, NSW. Contact Kate Chitty 02 9411 4991
Notes

Results