CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Simvastatindrug
Likely dose
Simvastatin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03896217
NCT03896217Phase 2Completed

A Double-blind, Randomised, Placebo-controlled Single-site Study of High Dose Simvastatin Treatment for Secondary Progressive Multiple Sclerosis: Impact on Vascular Perfusion and Oxidative Damage

University College, London·interventional·Posted Mar 29, 2019·Updated Jul 1, 2025

In Brief

A Phase 2 clinical trial evaluating Simvastatin for Secondary Progressive Multiple Sclerosis. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Multiple sclerosis (MS) is a neurological condition which is a common cause of disability in young people. It is thought to be an autoimmune condition, where the body's immune system begins to attack itself. The cause of MS is unknown but is thought to be a mix of genetic and environmental factors. There are treatments available for early stages of MS, but the later stage known as Secondary Progressive MS (SPMS) has no current treatment. Statins are a safe treatment traditionally used to reduce cholesterol levels. However, statins also have other effects which could reduce the progression of SPMS, such as effects on the immune system and circulation. A recent study (Chataway et al., 2014) showed that treatment with high-dose simvastatin, a type of statin, reduced the progression of SPMS but no effect on the immune system was seen. It is possible that simvastatin does not treat the immune system but improves how the blood and blood vessels in the brain work in this disease. The purpose of the clinical trial is to test how Simvastatin (80mg/day) may slow down disease progression in people living with SPMS compared to placebo (dummy pill). Participants will receive either Simvastatin or placebo and will be asked to take 2 tablets daily, for up to 17 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 29, 2019
Enrollment StartMay 16, 2019
Primary CompletionSep 13, 2022
Study CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.3 years ago

Interventions

Simvastatindrug

Simvastatin 40mg for first 4 weeks and 80mg (if tolerated) thereafter up to 17 weeks