THE MS-STAT TRIAL: A PHASE II TRIAL OF HIGH-DOSE SIMVASTATIN FOR SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS: BASELINE TRIAL PROFILE

BackgroundTherapeutic options for secondary progressive MS (SPMS) are very limited. Simvastatin is an attractive drug with potentially anti-inflammatory (e.g., reducing leukocyte migration) and neuro-protective effects (e.g., up-regulation of the major cell survival protein bcl-2), in addition to being well tolerated. In trials of early stage MS it is undergoing trials as a single agent or in combination therapy with standard disease modifying treatments. This is the first trial in SPMS.Trial OverviewDouble-blinded/placebo-controlled (1:1) with 80 mg of simvastatin. Two-year follow-up. Entry EDSS 4.0–6.5. Brain atrophy rate as determined from T1-weighted volumetric MRI using the brain boundary shift integral is the primary outcome measure. Secondary outcomes include disability scores, neuropsychological assessments and immunological profiling.Results408 patients were referred, 203 screen failures, 140/140 patients were randomised. Age 52 years (range 35–65), 68% female, MS duration 21 years (8) with a secondary progressive phase of 13 years (7). Median EDSS 6.0 (IQR 0.5). MSFC 10 m walk/s 23.6 (25.6); Nine-hole peg test/s 34.6 (13.2); PASAT/60 35.3 (14.2). MSIS-29ver 2.0 scores: physical 49/80 (11), psychological 20/36 (8), total 69/116 (14). All data as mean (SD) unless stated.ConclusionThis trial is fully recruited and will report in late 2011. ClinicalTrials.gov, number NCT00647348.