Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis - Full Text View

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Simvastatin

U.S. FDA Resources

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 ]

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

Arms	Assigned Interventions
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

Detailed Description:

The study has now completed and study data is in the process of being reviewed and correlated.

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

Locations

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

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Jeremy Chataway, MB BCh, PhD

Imperial College London

More Information

No publications provided

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
Study First Received:	March 26, 2008
Last Updated:	November 26, 2012
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

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013

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