Multiple Sclerosis (MS) is a progressive neurological disorder of the brain and spinal cord.
It affects approximately 120,000 people in the United Kingdom and 2.5 million people
globally. Most people with MS experience two stages of the disease:
Early MS - Relapsing-Remitting MS (RRMS), which is partially reversible, and Late MS -
Secondary Progressive MS (SPMS), which affects the majority of patients, usually after 10 to
15 years after diagnosis.
SPMS results from progressive neuronal degeneration that causes accumulating and irreversible
disability affecting walking, balance, manual function, vision, cognition, pain control,
bladder and bowel function. The pathological process driving the accrual of disability in
SPMS is not known at present.
Immunomodulatory anti-inflammatory disease modifying therapies (DMTs) are increasingly
effective in reducing relapse frequency in RRMS, however, they have been unsuccessful in
slowing disease progression in SPMS. This is the overwhelming conclusion from an analysis of
18 phase 3 trials (n=8500), of which 70% of the population had SPMS, all performed in the
last 25 years. There is no current disease modifying treatment (DMT) for SPMS.
In an earlier study (Multiple Sclerosis-Simvastatin 1; MS-STAT1), 140 people with SPMS were
randomly assigned to receive either placebo or simvastatin for a period of two years. The
investigators found that the rate of brain atrophy (loss of neurons - 'brain shrinkage'), as
measured by magnetic resonance imaging (MRI), was reduced in patients receiving simvastatin
compared to those taking placebo.
Several other long term studies have also reported that there might be a relationship between
the rate of brain atrophy and the degree of impairment. The study is designed to test the
effectiveness of repurposed simvastatin (80mg) in a phase 3 double blind, randomised, placebo
controlled trial (1:1) in patients with secondary progressive MS (SPMS), to determine if the
rate of disability progression can be slowed over a 3 year period.
The results generated from this trial may help to improve the treatment options of people
with MS. In addition, taking part in this trial will mean regular review by an experienced
neurologist regardless of the drug that patients are randomly allocated to receive.
Phase:
Phase 3
Details
Lead Sponsor:
University College, London
Collaborators:
Imperial College Healthcare NHS Trust London School of Hygiene and Tropical Medicine Queen Mary University of London The Leeds Teaching Hospitals NHS Trust University of Edinburgh University of Leeds