TheTOPICstudy.com            
MS Clinical Research Study

• Summary
• Rationale
• Eligibility and Details
• Learn More about the TOPIC Study
• You Can Help
• Study Centers Enrolling Patients in the TOPIC Study

Summary:top

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.

Rationale:top

Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. Teriflunomide is an agent that may decrease immune system activity in patients with 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 patients with MS are ongoing.

Eligibility and Details:top

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.

Patients must be scanned by the study center and randomized within 60 days of onset of symptoms.

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.

Learn More About the TOPIC study.

Please take a moment to download theTOPIC study brochure to learn more about this important clinical research study.

You Can Helptop

If you would like to support your local TOPIC study center in identifying possible participants for this important clinical research study, please take a moment to complete the simple form below. You will receive helpful TOPIC tools to educate and inform your patients about the TOPIC study.

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Study Centers Enrolling Patients
in the TOPIC Study:top

Below is a list of study centers that are currently enrolling patients. Please contact the study center nearest you for more information about the TOPIC study.

Active US Sites

• MS Clinic of Central Texas, Central Texas Neurology Consultants
  (512) 218-1222
  Round Rock, TX 78681
• Neurology Specialists, Inc.
  (937) 495-0000x142
  Dayton, OH 45417
• Fort Wayne Neurological Center
  (260) 436-3991x2143
  Fort Wayne, IN 46804
• Neurology Associates, P.A.
  (407) 647-5996x204
  Maitland, FL 32751
• LSUHSC Dept of Neurology
  (318) 813-1453
  Shreveport, LA 71103
• George Washington University, Dept of Neurology
  (202) 741-2717
  Washington, DC 20037
• Mount Sinai School of Medicine; Corinne Goldsmith Dickinson Center for MS
  (212) 241-7858
  New York, NY 10029
• University of Kentucky Medical Center
  (859) 218-5006
  Lexington, KY 40536
• MidAmerica Neuroscience Institute
  (913) 894-1500x151
  Lenexa, KS 66214
• Fletcher Allen Health Care, Dept of Neurology
  (802) 656-9915
  Burlington, VT 05405
• Saint Louis University, Dept of Neurology
  (314) 977-4867
  St. Louis, MO 63104
• SUNY Stony Brook Dept of Neurology
  (631) 444-3448
  Stony Brook, NY 11794
• Kelsey-Seybold Clinic
  (713) 442-1224
  Houston, TX 77025
• Josephson Wallack Munshower Neurology, PC
  (317) 537-6060
  Indianapolis, IN 46256
• The Neurological Institute, P.A.
  (704) 331-7856
  Charlotte, NC 28204
• NeuroTrials Research, Inc.
  (404) 851-9934
  Atlanta, GA 30342
• Xenoscience
  (602) 274-9500
  Phoenix, AZ 85004
• MS Specialty Clinic UNM
  (505) 272-0356
  Albuquerque, NM 87131
• Northern Michigan Neurology
  (231) 935-0340
  Traverse City, MI 49684
• Suncoast Neuroscience Associates, Inc.
  (727) 824-7135
  St. Petersburg, FL 33701
• St. Mary's Healthcare
  616-752-5435
  Grand Rapids, MI 49503
• Albert Einstein Medical Center, Neurosensory Sciences
  
  Philadelphia, PA 19141
• Baptist Neurology Center
  (859) 260-4388
  Lexington, KY 40503
• Regional MS Center at Regional MS Center at St. Lukes Medical Center
  (414) 649- 5097
  Milwaukee, WI 53215
• University of California, Irvine
  (949) 824-7524
  Irvine, CA 92697

Coming Soon (US)