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.

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

• Geelong Hospital
  Department of Neuroscience
  Level 2, Kardinia House
  Bellerine Street
  GEELONG VIC 3220
  Investigator: Dr. Caron Chapman
  Study Co-ordinator: Sharryn Savickas
  Phone: 03 5226 7950
  
• Royal Hobart Hospital
  Department of Neurology
  Liverpool Street
  HOBART Tasmania 7000
  Investigator: Assoc Prof. Bruce Taylor
  Study Co-ordinator: Sue McGregor
  Phone: 03 6220 1111
  
• Austin Hospital
  Austin Health
  Occupational Therapy Building
  145 Studley Road
  HEIDELBERG VIC 3084
  Investigator: Prof. Richard Macdonell
  Study Co-ordinator: Elise Heriot
  Phone: 03 9496 3705
  
• Flinders Medical Centre
  Neurology Department
  Flinders Drive
  Bedford, 5042
  Bedford SA 5042
  Investigator: Dr. Mark Slee
  Study Co-ordinator: Marie Toubia
  Phone: 08 8204 4971
  
• Gold Coast Hospital
  School of Medicine
  Griffith University
  Little High St, QLD 4222
  Little High St QLD 4222
  Investigator: Prof. Simon Broadley
  Study Co-ordinator: Susan Freeman
  Phone: 07 5678 0750