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

This study is currently recruiting participants.
Verified by Imperial College London, April 2008

Sponsored by: Imperial College London
Information provided by: Imperial College London
ClinicalTrials.gov Identifier: NCT00647348
  Purpose

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.


Condition Intervention Phase
Secondary Progressive Multiple Sclerosis
Drug: Simvastatin
Drug: Placebo
Phase II

MedlinePlus related topics:   Multiple Sclerosis   

ChemIDplus related topics:   Simvastatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   A Phase II Randomised, Placebo-Controlled Clinical Trial of Simvastatin in Patients With Secondary Progressive Multiple Sclerosis.

Further study details as provided by Imperial College London:

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 ]

Estimated Enrollment:   140
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2011
Estimated Primary Completion Date:   September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Simvastatin 80mg OD
Drug: Simvastatin
80mg simvastatin oral once daily for 24 months
2: Placebo Comparator
Placebo
Drug: Placebo
Oral placebo tablet once daily for 24 months

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647348

Contacts
Contact: David Wilkie, BA, MA     0044 (0) 208 383 0675     d.wilkie@imperial.ac.uk    

Locations
United Kingdom
Brighton & Sussex University Hospitals NHS Trust, Eastern Road     Not yet recruiting
      Brighton, United Kingdom, BN2 5BE
      Principal Investigator: Dennis Chan, MD, PhD            
United Kingdom, Buckinghamshire
MRI Unit, National Society for Epilepsy, Chesham Lane     Not yet recruiting
      Chalfont St. Peter, Buckinghamshire, United Kingdom, SL9 0RJ
      Principal Investigator: Jeremy Chataway, MB BCh; PhD            
United Kingdom, London
Charing Cross Hospital, Fulham Palace Road     Recruiting
      Hammersmith, London, United Kingdom, W6 8RF
      Principal Investigator: Richard Nicholas, MD, PhD            

Sponsors and Collaborators
Imperial College London

Investigators
Principal Investigator:     Jeremy Chataway, MB BCh, PhD     Imperial College London    
  More Information

Responsible Party:   Imperial College London ( Jeremy Chataway )
Study ID Numbers:   MSTC-001, EudraCT: 2006-006347-31, MREC: 07/Q1602/73
First Received:   March 26, 2008
Last Updated:   April 3, 2008
ClinicalTrials.gov Identifier:   NCT00647348
Health Authority:   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  
Simvastatin  
MRI  

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Simvastatin
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System
Multiple Sclerosis, Chronic Progressive

Additional relevant MeSH terms:
Antimetabolites
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Neoplastic Processes
Neoplasms
Pathologic Processes
Therapeutic Uses

ClinicalTrials.gov processed this record on September 05, 2008




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