Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis (MS-STAT)
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ClinicalTrials.gov Identifier: NCT00647348 |
Recruitment Status
:
Completed
First Posted
: March 31, 2008
Last Update Posted
: November 27, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Progressive Multiple Sclerosis | Drug: Simvastatin Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis. |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Simvastatin 80mg OD
|
Drug: Simvastatin
80mg simvastatin oral once daily for 24 months
|
Placebo Comparator: 2
Placebo
|
Drug: Placebo
Oral placebo tablet once daily for 24 months
|
- Quantitative MRI analysis to measure cerebral atrophy, and inflammation. [ Time Frame: Months 12 & 24 ]
- Evaluations of disability (EDSS, MSFC, MSIS-29), quality of life (SF-36), cognitive & behavioural function tests. Immunological assays to determine the pleiotropic effects of simvastatin on immune function. [ Time Frame: Months 12 & 24 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647348
United Kingdom | |
MRI Unit, National Society for Epilepsy, Chesham Lane | |
Chalfont St. Peter, Buckinghamshire, United Kingdom, SL9 0RJ | |
Charing Cross Hospital, Fulham Palace Road | |
Hammersmith, London, United Kingdom, W6 8RF | |
Brighton & Sussex University Hospitals NHS Trust, Eastern Road | |
Brighton, United Kingdom, BN2 5BE |
Principal Investigator: | Jeremy Chataway, MB BCh, PhD | Imperial College London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00647348 History of Changes |
Other Study ID Numbers: |
MSTC-001 EudraCT: 2006-006347-31 MREC: 07/Q1602/73 |
First Posted: | March 31, 2008 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
Keywords provided by Imperial College London:
Secondary progressive Multiple Sclerosis Simvastatin MRI |
Additional relevant MeSH terms:
Sclerosis Multiple Sclerosis Neoplasm Metastasis Multiple Sclerosis, Chronic Progressive Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Neoplastic Processes Neoplasms Simvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |