Sunday, January 11, 2009

MS Trial: Oral Teriflunomide

I found the following information on the National MS Society web page.

Dec 30, 2008
MS Trial Alert: Study of Oral Teriflunomide (HMR1726) Added on to Copaxone Recruiting People with Relapsing Forms of MS Worldwide
Summary: Investigators at six sites in the United States and others around the world are recruiting 120 people with relapsing forms of multiple sclerosis (MS) for a study comparing two doses of teriflunomide (HMR1726), an investigational, oral MS medication, or inactive placebo, in people taking the approved drug Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries). For the purposes of this study, "relapsing forms of MS" would include individuals who have experienced one MS attack in the past one year or two MS attacks in the past two years. The study is sponsored by Sanofi-Aventis.
Rationale: Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is an agent that may decrease immune system activity in MS. Combining this experimental oral therapy with a moderately effective standard therapy may boost therapeutic benefits. Other studies of teriflunomide in MS are ongoing.
Eligibility and Details: People eligible for participation include individuals 18-55 years of age with relapsing forms of MS who have received Copaxone 20 mg/day subcutaneously for at least 26 weeks.
Participants will be randomly assigned to receive – in addition to Copaxone – either 7 mg teriflunomide, 14 mg teriflunomide, or placebo once daily for 24 weeks. The main goal of the study is to determine safety and tolerability. Other goals include evaluating disease activity as observed on MRI scans and relapse rate.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact a study center near you:
Phoenix, AZPhoenix Neurological AssociatesContact: (602)-258-3354;
Walnut Creek, CAThe Neurological Research Institute of East BayContact: (925)-938-5252;
Jacksonville, FLUniversity of Florida Neuroscience InstituteContact: (904)-244-9814;
Tampa, FLMeridian ResearchContact: (813)-877-8839;
Albany, NY Upstate Clinical Research LLCContact: (518)-533-1543;
San Antonio, TXIntegra Clinical Research, LLCContact: (210)-568-0261;

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