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Clinical Development of Teriflunomide in Multiple Sclerosis

Several clinical research studies are planned or ongoing to investigate the efficacy and safety of teriflunomide as an oral treatment for patients with multiple sclerosis (MS):

TEMSO

An ongoing phase III clinical research trial evaluating the efficacy and safety of teriflunomide compared with placebo, or sham treatment, in patients with MS with relapses [1]. The trial will compare the effects of teriflunomide versus placebo treatment on patients’ disability status. Results from this drug trial are expected to be published in 2010.

TEMSO Extension Study

MS patients who complete the TEMSO trial will be invited to participate in a 2-year extension study in which they will receive one of two doses of teriflunomide [2]. This research study will evaluate the long-term safety of teriflunomide at the two different doses and their effects on disability progression.

TENERE

A one-year, phase III trial, TENERE, is also ongoing and is comparing the efficacy and safety of teriflunomide versus interferon beta-1a, an approved therapy for MS [3]. The trial will measure the efficacy of teriflunomide and its effects on relapse rates in patients with relapsing-remitting multiple sclerosis (RRMS). The trial is due for completion in 2011.

TOPICS

The phase III clinical trial, TOPICS, is investigating the efficacy and safety of once-daily teriflunomide compared with placebo in patients with a first clinical episode suggestive of MS (termed Clinically Isolated Syndrome or CIS) [4]. The trial aims to evaluate the potential of teriflunomide to delay the onset of MS. Data from the trial are expected to be published in 2012.

Phase III Efficacy Study of Teriflunomide in RRMS

Another phase III clinical trial will compare the efficacy and safety of teriflunomide versus placebo in patients with RRMS [5]. The trial will evaluate the effects of two different doses of teriflunomide, compared with placebo, on relapse rates, disability and fatigue. The trial is due for completion in 2011.

Phase II Trials

A completed phase II drug trial [6] will be extended to investigate the long-term safety and efficacy of teriflunomide in patients with MS with relapses [7]. Data are expected in 2011.

Two small phase II studies have assessed the safety, tolerability, characteristics and metabolism of teriflunomide when given to patients with relapsing MS in combination with the approved MS treatments, glatiramer acetate (Copaxone®) and interferon beta-1a [8,9]. A long-term extension to these two trials will continue to evaluate the safety of teriflunomide when given to MS patients with relapses in combination with these two approved agents [10]. The researchers are expected to publish their results shortly.

More About Teriflunomide

  • An Introduction to Teriflunomide
  • Mechanism of Action of Teriflunomide

References

  1. A summary of the phase III TEMSO trial of teriflunomide in MS is available on clinicaltrials.gov.
  2. A summary of the two-year TEMSO extension study of teriflunomide in MS is available on clinicaltrials.gov. Accessed 8 June 2009 at the following URL: http://clinicaltrials.gov/ct2/show/NCT00803049?term=teriflunomide&rank=9
  3. A summary of the one-year phase III TENERE trial of teriflunomide in MS is available on clinicaltrials.gov. Accessed 8 June 2009 at the following URL: http://clinicaltrials.gov/ct2/show/NCT00883337?term=teriflunomide&rank=2
  4. A summary of the phase III TOPICS trial of teriflunomide in MS is available on clinicaltrials.gov.
  5. A summary of a phase III efficacy study of teriflunomide in RRMS is available on clinicaltrials.gov. Accessed 8 June 2009 at the following URL: http://clinicaltrials.gov/ct2/show/NCT00751881?term=teriflunomide&rank=4
  6. 6.O’Connor PW, Li D, Freedman MS, et al. A Phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology. 2006; 66(6): 894−900.
  7. A summary of a long-term safety and efficacy phase II study of teriflunomide in MS is available on clinicaltrials.gov. Accessed 8 June 2009 at the following URL:  http://clinicaltrials.gov/ct2/show/NCT00228163?term=teriflunomide&rank=5
  8. Freedman M, Wolinsky JS, Byrnes WJ, et al. Oral teriflunomide or placebo added to interferon beta for 6 months in patients with relapsing multiple sclerosis: safety and efficacy results. Abstract P878. Presented at: 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Dϋsseldorf, Germany, 9–12 September, 2009. Mult Scler 2009;15(9): S273.
  9. 9.Freedman M, Wolinsky JS, Frangin GA, et al. Oral teriflunomide or placebo added to glatiramer acetate for 6 months in patients with relapsing multiple sclerosis: Safety and efficacy results. Abstract S21.001. Presented at: 62nd Annual Meeting of the American Academy of Neurology (AAN), Toronto, Ont., Canada, 10–17 April, 2010. Neurology 2010;74(9, Suppl. 2):A293.
  10. A summary of a long-term, phase II extension trial of teriflunomide in combination therapy in MS is available on clinicaltrials.gov. Accessed 8 June 2009 at the following URL: http://clinicaltrials.gov/ct2/show/NCT00811395?term=teriflunomide&rank=8