Jun 12, 2008

MS Trial Alert: Study of Oral Teriflunomide (HMR1726) Recruiting People at High Risk for MS Worldwide

Summary:

Investigators worldwide are recruiting people at high risk for multiple sclerosis (MS) for a study comparing two doses of oral HMR1726 (teriflunomide), an immune system-modulating agent, and inactive placebo. People at high risk for MS are those who experience a clinically isolated syndrome (CIS, a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and brain magnetic resonance imaging findings suggestive of MS. 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. Results of a study in 179 patients evaluating the effects of teriflunomide in patients with known MS were reported by Paul O’Connor, MD (University of Toronto) and colleagues. Participants were randomly assigned to receive inactive placebo, or one of two doses (7 mg or 14 mg) of teriflunomide, once daily for 36 weeks. Both treatment doses were associated with reduced numbers of active brain lesions compared with placebo, and the drug was well tolerated (Neurology 2006 Mar 28;66(6):894-900). Other studies of teriflunomide in MS are ongoing.

Eligibility and Details:

People eligible for participation include individuals 18-55 years of age who experience a clinically isolated syndrome (a single neurological event suggestive of demyelination, such as focal weakness, numbness, coordination problems, or decrease in vision in one eye) and magnetic resonance imaging findings suggestive of MS.

Participants will be randomly assigned to receive 7 mg teriflunomide, 14 mg or placebo once daily for 108 weeks (about 2 years). The main outcome measure of the study is to determine whether the study drug reduces the time to conversion to clinically definite MS significantly more than placebo. Other measures will be followed including functioning of patients and changes in brain MRI scanning.

Contact: For further information, please contact a study site near you. Those currently enrolling in the United States are listed below. For updates on study sites in the future, please visit our database oftrials recruiting patientsor the study listing onclinicaltrials.gov(identifier: NCT00622700).

ArizonaNeurological Physicians of Arizona, Gilbert, AZContact: (480) 610-0177;neuro@crastudies.com

FloridaAxiom Clinical Research of Florida, Tampa, FLKathleen Carlson, RN, CCRC,kcarlson.axiom@verizon.net, 813-353-9613 (x2)

Neurology Associates, P.A., Maitland, FLJerri Olson,neurologyassoc@hotmail.com, 407-647-5996 (X241)

IndianaFort Wayne Neurological Center, Fort Wayne, INMolly Miller,mmiller@fwnc.com, 260-436-3991 (X2143)

KansasMidAmerica NeuroScience Research Institute, Lenexa, KSLeAnn Cannon, LPN, CCRC,lcannon@neurokc.com, (913) 894-1500, ext 151

New YorkUpstate Clinical Research, LLC, Albany, NYMyra Edmunds, LPN, CCRC,medmunds@upstateneurology.com, 518-533-1543

OhioNeurology Specialists LLC, Dayton, OHLyle Wiemerslage,lyle.wiemerslage@nsohio.com, 937-495-0000 (x141)

TexasCentral Texas Neurology Consultants - MS Clinic of Central Texas, Round Rock, TXLori Mayer, RN, MSCN,Ms_research@sbcglobal.net, 512-218-1222 (x205)

-- Research and Clinical Programs Department