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

This study is currently recruiting participants.
Study NCT00647348.   Last updated on April 3, 2008.   Information provided by Imperial College London

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Descriptive Information Fields
Brief Title  Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis
Official Title  A Phase II Randomised, Placebo-Controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.
Brief Summary

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.

Detailed Description
Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Quantitative MRI analysis to measure cerebral atrophy, and inflammation. [ Time Frame: Months 12 & 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Secondary Progressive Multiple Sclerosis
Intervention  Drug: Simvastatin
Drug: Placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  140
Start Date  January 2008
Completion Date January 2011
Eligibility Criteria 

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
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: David Wilkie, BA, MA     0044 (0) 208 383 0675     d.wilkie@imperial.ac.uk    
Location Countries  United Kingdom
Administrative Information Fields
NCT ID  NCT00647348
Organization ID MSTC-001
Secondary IDs †† EudraCT: 2006-006347-31, MREC: 07/Q1602/73
Study Sponsor  Imperial College London
Collaborators ††
Investigators 
Principal Investigator:     Jeremy Chataway, MB BCh, PhD     Imperial College London    
Information Provided By Imperial College London
Verification Date April 2008
First Received Date  March 26, 2008
Last Updated Date April 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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