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Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis (MS-STAT)
This study is currently recruiting participants.
Study NCT00647348   Information provided by Imperial College London
First Received: March 26, 2008   Last Updated: April 3, 2008   History of Changes

March 26, 2008
April 3, 2008
January 2008
September 2010   (final data collection date for primary outcome measure)
Quantitative MRI analysis to measure cerebral atrophy, and inflammation. [ Time Frame: Months 12 & 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647348 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis
A Phase II Randomised, Placebo-Controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.

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.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Secondary Progressive Multiple Sclerosis
  • Drug: Simvastatin
  • Drug: Placebo
  • Active Comparator: Simvastatin 80mg OD
  • Placebo Comparator: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
140
January 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: David Wilkie, BA, MA 0044 (0) 208 383 0675 d.wilkie@imperial.ac.uk
United Kingdom
 
NCT00647348
Jeremy Chataway, Imperial College London
MSTC-001, EudraCT: 2006-006347-31, MREC: 07/Q1602/73
Imperial College London
 
Principal Investigator: Jeremy Chataway, MB BCh, PhD Imperial College London
Imperial College London
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP