TheTOPICstudy.com
MS Clinical Research Study

• Summary
• Rationale
• Eligibility and Details
• Learn More about the TOPIC Study
• You Can Help
• Study Centres 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 centre 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 centre 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 Centres Enrolling Patients
in the TOPIC Study:top

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

Active Sites

• The Royal London Hospital, Department of Neurology
  City: London
  Investigator: Dr. Ben Turner
  Phone: 0207 377 7000
  Email: Benjamin.Turner@bartsandthelondon.nhs.uk
  Study Co-ordinator: Sara Soudain
  Phone: 0207 882 8439
  
• The Royal Hallamshire Hospital, Department of Neurology
  City: Sheffield
  Investigator: Dr. Sian Price
  Phone: 0114 2711977
  Email: Sian.Price@sth.nhs.uk
  
• St. George's Hospital, Department of Neurology
  City: London
  Investigator: Dr. David Barnes
  Phone: 0208 725 4631
  Email: David.Barnes@stgeorges.nhs.uk
  Study Co-ordinator: Christine Gregory
  Phone: 0208 725 4631
  
• Queens Medical Centre, Division of Clinical Neurology
  City: Nottingham
  Investigator: Dr. Nikos Evangelou
  Phone: 0115 849 3285
  Email: nikos_evangelou@nuh.nhs.uk
  Study Co-ordinator: Kathryn Hewitt
  Phone: 01158493285
  Email: kathryn.hewitt@nuh.nhs.uk
  
• Greater Manchester Neurosciences Centre
  City: Manchester
  Investigator: Dr. David Rog
  Phone: 0161 206 0534
  Email: David.Rog@srft.nhs.uk
  Study Co-ordinator: Stephanie Mitchell
  Phone: 0161 206 0534