A Phase II randomised placebo controlled clinical trial of Simvastatin in patients with secondary progressive multiple sclerosis

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive

• Registration Number: EUCTR2006-006347-31-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Patients must have a confirmed diagnosis of multiple sclerosis and have progressed to the secondary progressive stage.
EDSS 4.0 to 6.5 inclusive
Men and women to be included (women of childbearing age must take effective methods of contraception)
Able to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unable to give written informed consent
Patients with primary progressive MS
Those that have experienced a relapse or have been treated with steroids within 3 months of the screening visit
Patients on any medications that unfavourably react with statins e.g. fibrates, nicotinic acid, cyclosporine, azole etc.
Patients on immunosuppressive medicines e.g. avonex, rebif, betaferon etc within the previous 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 with placebo.;<br> Secondary Objective: Scores of disability (physical and psychological) and immunological parameters, MRI measures of inflammation.<br><br> ;<br> Primary end point(s): To quantify global brain volume loss from serial MRIs, tightly controlled for reproducability acquisition over time reported as an annual percentage brain loss.<br><br> To assess the rate of accumulating disability over the trial period using a number of scales ( EDSS, MSIS-29, MSFC and SF-36) plus cognitive and behavioural fuction assessments.<br>