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| Sponsor: | 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: | 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. |
| 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 |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David Wilkie, BA, MA | 0044 (0) 208 383 0675 | d.wilkie@imperial.ac.uk |
| United Kingdom | |
| 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 | |
| Charing Cross Hospital, Fulham Palace Road | Recruiting |
| Hammersmith, London, United Kingdom, W6 8RF | |
| Principal Investigator: Richard Nicholas, MD, PhD | |
| Brighton & Sussex University Hospitals NHS Trust, Eastern Road | Not yet recruiting |
| Brighton, United Kingdom, BN2 5BE | |
| Principal Investigator: Dennis Chan, MD, PhD | |
| Principal Investigator: | Jeremy Chataway, MB BCh, PhD | Imperial College London |
More Information
| Responsible Party: | Jeremy Chataway, 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: | April 3, 2008 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
|
Secondary progressive Multiple Sclerosis Simvastatin MRI |
|
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 |