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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006347-31-GB

Enrollment

140

Registered

2007-08-07

Start date

2007-09-06

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Encapsulated Simvastatin tablets Product Code: MSTC-001 (MS-STAT) Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: Scores of disability (physical and psychological) and immunological parameters, MRI measures of inflammation. ; 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. 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.	—

Measure

Time frame

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.; Secondary Objective: Scores of disability (physical and psychological) and immunological parameters, MRI measures of inflammation. ; 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. 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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026