Full Text View
Tabular View
No Study Results Posted
Related Studies
Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis (MS-STAT)
This study is currently recruiting participants.
Verified by Imperial College London, April 2008
First Received: March 26, 2008   Last Updated: April 3, 2008   History of Changes
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

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.

Resource links provided by NLM:


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

No publications provided

Responsible Party: Imperial College London ( Jeremy Chataway )
Study ID Numbers: MSTC-001, EudraCT: 2006-006347-31, MREC: 07/Q1602/73
Study First Received: March 26, 2008
Last Updated: April 3, 2008
ClinicalTrials.gov Identifier: NCT00647348     History of Changes
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:
Antimetabolites
Autoimmune Diseases
Demyelinating Diseases
Simvastatin
Antilipemic Agents
Sclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Antimetabolites
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Demyelinating Diseases
Immune System Diseases
Simvastatin
Antilipemic Agents
Nervous System Diseases
Enzyme Inhibitors
Sclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Multiple Sclerosis, Chronic Progressive
Neoplastic Processes
Neoplasms
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on July 02, 2009