The TOPIC study A trial comparing teriflunomide to a placebo in people newly diagnosed with multiple sclerosis Multiple sclerosis (MS) is caused by the immune system attacking the brain and spinal cord. Teriflunomide is a drug that may decrease the level of this attack in people with MS. Results of a previous trial in 179 people with MS showed that teriflunomide reduced the number of brain lesions detected by MRI. Teriflunomide is similar to the drug leflunomide, also known as Arava®, which is already approved in many countries for the treatment of rheumatoid arthritis. This trial aims to test the safety and effectiveness of teriflunomide to see whether early treatment can reduce the severity of symptoms associated with MS. Phase Phase III Recruitment Start: February 2008 End: April 2011 Who can enter the trial You can take part in this trial if: • You have had a first acute or subacute, well-defined neurological event consistent with demyelination (i.e.optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes) • You have had an onset of MS symptoms occurring within 60 days after being allocated at random to the treatment groups in the trial (randomisation) • You have a MRI scan showing two or more T2 lesions at least 3mm in diameter that are characteristic of MS. Exclusion Criteria You cannot take part in this study if: • You have a clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease • You have significantly impaired bone marrow function • You are pregnant or nursing • You have a history of alcohol or drug abuse • You have been treated with any of the following medications or procedures prior to taking part in the study: Cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate • There are any other reasons that, in the opinion of the Investigator and/or the Sponsor, you are determined to be unsuitable for enrolment in this study • Other criteria apply which your doctor will discuss with you. Trial design This is a randomised, parallel-group, double blind, parallel arm trial comparing two doses (7mg or 14mg) of teriflunomide with a placebo. People in both the placebo and treatment groups of the trial will take 1 tablet a day in the morning. The study aims to enroll 780 people with MS. How many times (and how often) they have treatment This study consists of three stages: 1. The screening phase: This phase will take up to four weeks 2. The treatment phase: Both the treatment and placebo groups will take one tablet a day for 108 weeks 3. The post-treatment phase: After people have completed their treatments and are no longer receiving any medication, two follow visits will be required, the first at four weeks and the second at 16 weeks (Washout procedure). There may also be the option to take part in an extension study where participants will have the choice to continue taking the drug after the trial has ended. Participants in the extension study will not be required to undergo stage three above. Side effects More side effects were reported for the higher dose taken in previous trials. Known side effects include nausea, headaches, diarrhoea, and limb pain. UK locations of the trial • The Royal London Hospital, Department of Neurology City: London Investigator: Dr. Ben Turner Phone: 0207 377 7000 Email: [email protected] Study Co-ordinator: Krzysztof Rutkowski Email: [email protected] • The Royal Hallamshire Hospital, Department of Neurology City: Sheffield Investigator: Dr. Sian Price Phone: 0114 2711977 Email: [email protected] • University Hospital of North Staffordshire, Department of Neurology City: Stoke on Trent Investigator: Prof. Clive Hawkins Phone: 01782 555008 Email: [email protected] Study Co-ordinator: Sharon Hurlstone Phone: 01782 555008 • St. George's Hospital, Department of Neurology City: London Investigator: Dr. David Barnes Phone: 0208 725 4631 Email: [email protected] Study Co-ordinator: Christine Gregory Phone: 02087254162 • Queens Medical Centre, Division of Clinical Neurology City: Nottingham Investigator: Dr. Nikos Evangelou Phone: 0115 849 3285 Email: [email protected] Study Co-ordinator: Kathryn Hewitt Phone: 01158493285 Email: [email protected] • Greater Manchester Neurosciences Centre City: Manchester Investigator: Dr. David Rog Phone: 0161 206 0534 Email: [email protected] Study Co-ordinator: Stephanie Mitchell Phone: 0161 206 0534 Contact details If you are interested in taking part please discuss this information with your neurologist or GP.
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