SIMSON trial
What it found
No result yet.
What was tested
Treatment tested
- Simvastatin
HMG-CoA reductase inhibitor
What it measured
Main measures
The change in whole brain atrophy rate, comparing rates during 6-month run-in period to 18-month treatment period.
Brain volume loss
Other measures (1)
Secondary outcome measures include clinical outcome measures (neurological exam, arm- and walking functions, cognitive functions), biochemical outcome measures (sNfL, multi-parameter analysis of peripheral blood mononuclear cells (PBMC) and serum cholesterol), other imaging outcome measures (regional white and gray matter atrophy rate, functional connectivity on brain MRI, OCT), patient-reported o
MRI lesionsBrain volume lossRetina scans (OCT)Thinking and memoryWalking and mobilityArm and hand functionNerve conduction testsQuality of life (reported by participants)Safety
Who could take part
MS (type not specified)
Inclusion: 1. Definite diagnosis of multiple sclerosis (MS) according to the revised McDonald 2017 criteria. Exclusion: 1. MS relapse within 6 months of baseline visit, with or without treatment with steroids.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To assess the efficacy of add-on high-dose simvastatin in MS patients treated with natalizumab or ocrelizumab for at least six months on whole brain atrophy rate.
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History
Started
Apr 2020
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