FTY720 for relapsing-remitting multiple sclerosis

• Research type

  Research Study

• Full title

  A 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.

• IRAS ID

  5878

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-002096-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple Sclerosis (MS) is themost common disabling disease of the central nervous system (brain and nervesof the spinal cord) in young adults. The cause of MS is unknown. It is anautoimmune disease, where white blood cells (lymphocytes) start to attack partsof the brain. Relapsing-Remitting Multiple Sclerosis (RRMS) is characterised bya steady worsening of symptoms but also periods where the patient is stable andnot experiencing any symptoms. Patients with RRMS are given treatment for theirsymptoms via an injection, however these often have side effects such asinjection site reactions and flu-like symptoms. FTY720 (the study drug) is apossible new oral treatment (tablet) taken once daily for RRMS. FTY720 acts onthe white blood cells responsible for the immune reactions and makes the cellsmove away from the sites of inflammation. The white blood cells are redirectedto the lymph nodes and other places where they normally rest. Theanti-inflammatory effects of FTY720 have been shown in previous studies inother forms of MS. Each patient who signs consent and meets the inclusioncriteria, will undergo examinations to determine that they are eligible to jointhe study. Patients who enter the study have 2 in 3 chance of receiving activestudy drug. Each patient will visit the clinic 10 times during the first yearand then another 4 times every three months in the second year. A patient??sparticipation in the study is expected to last up to 25 months. The study isbeing run by Novartis Pharma AG. Approximately 1080 patients from across theworld will be recruited into the study of which 5-8 patients will be recruitedin the UK.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  08/H0502/129

• Date of REC Opinion

  28 Nov 2008

• REC opinion

  Further Information Favourable Opinion