Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis (MS-STAT)
This study has been completed.
Information provided by (Responsible Party):
Imperial College London
First received: March 26, 2008
Last updated: November 26, 2012
Last verified: November 2012
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.
Secondary Progressive Multiple Sclerosis
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Phase II Randomised, Placebo-controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.
Primary Outcome Measures:
- Quantitative MRI analysis to measure cerebral atrophy, and inflammation. [ Time Frame: Months 12 & 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2011 (Final data collection date for primary outcome measure)
Active Comparator: 1
Simvastatin 80mg OD
80mg simvastatin oral once daily for 24 months
Placebo Comparator: 2
Oral placebo tablet once daily for 24 months
The study has now completed and study data is in the process of being reviewed and correlated.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647348
|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 |
Imperial College London
||Jeremy Chataway, MB BCh, PhD
||Imperial College London
No publications provided
||Imperial College London
History of Changes
|Other Study ID Numbers:
||MSTC-001, EudraCT: 2006-006347-31, MREC: 07/Q1602/73
|Study First Received:
||March 26, 2008
||November 26, 2012
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
Keywords provided by Imperial College London:
Secondary progressive Multiple Sclerosis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors