MS-SMART: MS-Secondary Progressive Multi-Arm Randomisation Trial
MS-SMART: A Multi-Arm Phase IIb Randomised, Double Blind Placebo-Controlled Clinical Trial Comparing The Efficacy of 3 Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis
Multiple sclerosis is the commonest disabling neurological disease affecting young adults in temperate latitudes. It is a progressive disorder of the brain and spinal cord. Many patients with MS experience two phases of disease: (i) early MS (relapsing remitting MS) and (ii) late MS, secondary progressive MS (SPMS), affecting the majority of patients after 10-15 years. SPMS results from nerve death that causes accumulating and irreversible disability. There is no proven treatment for SPMS and it is a major unmet health need for the NHS. These patients require nerve protection treatments that will slow, stop and ultimately reverse progressive disease. A systematic review of all relevant pre-clinical and clinical data by the MS Clinical Trials Network and an international MS expert workshop led to the identification of three leading drugs (Ibudilast, Riluzole or Amiloride) suitable to trial in SPMS. The MS-SMART trial will test these drugs in 440 SPMS patients using a simultaneous multi-arm trial design, each compared against a dummy drug (placebo). Patients will be on the trial for up to week 100 (approximately 25 months) and will be recruited from specialist centres within the UK. Patients and treating trial clinician will not know which drug they are receiving to enable an unbiased testing of the drugs. All patients will have MRI (magnetic resonance imaging) brain scans and after 96 weeks these will be analysed to determine which drugs are the most promising. The main (primary) outcome is change in MRI, to see if any of the drugs can slow the rate of brain shrinkage that we would normally see in SPMS, supported by lesion and disability changes, compared to being on the dummy drug. This trial is a world-first in MS, with great economies of scale.
Scotland A REC
Date of REC Opinion
28 Jan 2013