CBAF312A2304 siponimod in secondary progressive multiple sclerosis v1

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of siponimod (BAF312) in patients with secondary progressive multiple sclerosis

• IRAS ID

  113121

• Contact name

  Jane Watson

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-003056-36

• Clinicaltrials.gov Identifier

  NCT01665144

• Research summary

  Multiple Sclerosis (MS) is the most common disabling disease of the Central Nervous System (brains and spinal cord) in young adults.The cause of MS is unknown.  It is an autoimmune disease, where the white blood cells (lymphocytes) start to attack the nerves and parts of the brain.  There are several types of MS, the most common of which is Relapsing Remitting MS (RRMS). Patients with RRMS have repeated acute episodes of neurological symptoms (relapses) which are followed by complete or partial recovery (remission). After 6 to 10 years 30-40% of patients with RRMS have progressed to secondary progressive MS (SPMS) which is a stage of the disease characterised by continuous worsening of disability with or without relapses.Siponimond (BAF312) the study drug works in a similar way to fingolimod (Gilenya currently prescribed for the treatment of RRMS). It acts on the white blood cells responsible for immune reactions and makes cells move away from the sites of inflammation. The purpose of this study is to see if siponimod is safe and beneficial to people with SPMS.Each patient who signs the informed consent form and meets inclusion criteria will undergo examinations to determine if they are eligible to join the study. Patients who enter the study have a 2 in 3 chance of receiving the active study drug.Each patient will visit the clinic at least nine times during the first 12 months and then every three months until the end of the study. A patient's participation in the study is expected to be between 23 and 42 months. This study is being run by Novartis Pharma AG.  Approximately 1530 patients from across the world will enter the study (60 from the UK).

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  13/SC/0092

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion