Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects
approximately 100,000 people in the UK. Many patients with MS experience two phases of
disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called
secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the
insulation (called myelin) that surrounds the nerves. Early MS is often characterised by
periods of "attacks" interspersed with periods of "remission" with no or low disease
symptoms. Late or progressive MS, which affects the majority of patients and typically
emerges after 10-15 years of disease, results from actual nerve death (also called
neurodegeneration). The progressive stage of disease results not in individual attacks but
slow, cumulative and irreversible disability affecting walking, balance, vision, cognition,
pain control, bladder and bowel function. Critically, and unlike early disease, there is no
proven treatment for the late stage of MS. This is therefore an urgent and major unmet health
need. MS-SMART directly addresses this need and will evaluate in this clinical trial three
drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in
particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get
any one of the three active drugs or the inactive placebo/dummy; blinded means that neither
patients nor the doctors will know which drug or placebo patients are receiving.
Randomisation and blinding are standard approaches in clinical trials to ensure unbiased
testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance
imaging) brain scans and after 96 weeks these will be analysed. We will then compare the
scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain
shrinkage that normally occurs in SPMS. This measured change in brain size is the primary
(major) outcome of MS-SMART.
Phase:
Phase 2
Details
Lead Sponsor:
University College, London
Collaborators:
Keele University Medical Research Council MS Society National Institute for Health Research, United Kingdom Queen Mary University of London University of Edinburgh University of Leeds University of Sheffield University of Warwick