Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis (MS-STAT)

Imperial College London

Status and phase

Completed

Phase 2

Conditions

Secondary Progressive Multiple Sclerosis

Treatments

Drug: Simvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00647348

MREC: 07/Q1602/73 (Other Identifier)

MSTC-001

2006-006347-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least one point on the EDSS or clinical documentation of increasing disability.
EDSS 4.0 - 6.5 inclusive
Women of childbearing age will be required to use appropriate methods of contraception to avoid the unlikely teratogenic effects of simvastatin.
Able to give written informed consent
18 - 65 years

Exclusion criteria

Unable to give informed consent
Primary progressive MS
Those that have experienced a relapse or have been treated with steroids (both i.v. and oral) within 3 months of the screening visit. These patients may undergo a further screening visit once the 3 month window has expired and may be included if no steroid treatment has been administered in the intervening period.
Patient is already taking or is anticipated to be taking a statin.
Any medications that unfavourably interact with statins: fibrates, nicotinic acid, cyclosporine, azole anti-fungal preparations, macrolideantibiotics, protease inhibitors, nefazodone, verapamil, amiodarone, large amounts of grapefruit juice or alcohol abuse.
The use of immunosuppressants (e.g. azathioprine, methotrexate, cyclosporine) or disease modifying treatments (avonex, rebif, betaferon, glatiramer) within the previous 6 months.
The use of mitoxantrone if treated within the last 12 months.
If the patient has ever been treated with alemtuzumab.
If screening levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatine kinase (CK) are three times the upper limit of normal patients should be excluded.
Patient unable to tolerate baseline scan or scan not of adequate quality for analysis (e.g. too much movement artefact).
If a female patient is pregnant or breast feeding