NCT00647348

Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis

A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.

Detailed description

The study has now completed see Primary publication: Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial. Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R. Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4.

Conditions

• Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Simvastatin	80mg simvastatin oral once daily for 24 months
DRUG	Placebo	Oral placebo tablet once daily for 24 months

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2008-03-31
• Last updated: 2019-12-12
• Results posted: 2019-12-12

Locations

3 sites across 1 country: United Kingdom