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This trial will aim to determine whether the novel application of simvastatin to treat secondary progressive multiple sclerosis reduces the rate of brain atrophy as determined by Magnetic Resonance Imaging. It will also determine the effect on the clinical and immunological course of the disease over a 2-year time-period.
Title
A phase II randomised placebo-controlled clinical trial of simvastatin in patients with secondary progressive multiple sclerosis (SPMS)
Study Location
- Hammersmith Hospitals NHS Trust (Charing Cross site)
- MRI Unit, National Centre for Epilepsy, Chalfont St. Peter (UCLH)
- Hurstwood Park Neurosciences Centre, Haywards Heath
Study Objectives
- To determine the efficacy of simvastatin in reducing the rate of whole brain atrophy in patients with SPMS as determined by MRI.
- To evaluate the effects of simvastatin on the clinical, neuropsychological and immunological course of MS over a two-year period.
Study Design
Randomised, placebo-controlled, double blind parallel group.
Sample size & patient selection
140 SPMS patients with documented progression in the preceding 2 years and EDSS 4.0 - 6.5 will be recruited and randomised 1:1 into active and placebo arms. Both male and female patients, age 18-65 will be included.
Dosing regimen
- Treatment group: Initially 40mg of simvastatin per day, escalating after one month to 80mg per day, provided no adverse events
- Placebo group: Initially 40mg of simvastatin placebo per day, escalating after one month to 80mg of simvastatin placebo per day, provided no adverse events
Summary of outcome measures
- Quantitative MRI investigations of cerebral atrophy and inflammation
- Evaluations of disability (EDSS, MSFC, MSIS-29), quality of life (SF-36), cognitive & behavioural function tests.
- Immunological assays to determine the pleiotropic effects of simvastatin on immune function.
Duration of patient involvement
24 months
Total study period
3 years
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If you require any help, please contact: Bella Polito Email: b.polito@imperial.ac.uk |
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