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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00094172 |
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients.
Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a state of immunological tolerance.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: Atorvastatin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Atorvastatin in Patients With Clinically Isolated Syndrome and High Risk of Conversion to Multiple Sclerosis |
Estimated Enrollment: | 152 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Atorvastatin
atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated
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2: Placebo Comparator |
Drug: Placebo
tablet form
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CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS patients may have a loss of vision in one eye; trouble with balance; double vision; numbness in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may develop MS, but others may not. Studies have shown that when CIS is accompanied by magnetic resonance imaging (MRI)-detected brain lesions that are consistent with those seen in MS, there is a high risk of a second neurologic event and a diagnosis of MS within several years. This study will evaluate the efficacy of atorvastatin, an antihyperlipidemic, in the prevention of MS in CIS patients.
This study will last 18 months. All participants must complete a 3- to 5-day course of corticosteroids at least 28 days before the baseline evaluations. This corticosteroid therapy must be initiated within 60 days of CIS onset. Participants will be randomly assigned to receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months. Study visits will occur at screening and every 3 months thereafter until the end of the 18-month study. Blood collection will occur at selected visits, and other additional evaluations will be performed at Months 1 and 2. Selected participants will undergo MRI brain scans. Participants will be offered interferon beta-1a (Avonex®), free of charge, if they develop disease activity. Participants will be instructed to report any change in their health status to their treating physician within 48 hours of the onset of symptoms.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Barrow Neurological Institute | |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
Keck School of Medicine | |
Los Angeles, California, United States, 90033 | |
United States, Connecticut | |
Yale MS Research Center | |
New Haven, Connecticut, United States, 06510 | |
United States, Maryland | |
Johns Hopkins | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington University Multiple Sclerosis Center | |
St Louis, Missouri, United States, 63110 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
Jacobs Neurological Institute | |
Buffalo, New York, United States, 14203 | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97201 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75930 | |
United States, Washington | |
Virginia Mason MS Center | |
Seattle, Washington, United States, 98111 | |
Canada, Quebec | |
Montreal Neurological Institute | |
Montreal, Quebec, Canada, H3A 2B4 |
Study Chair: | Scott Zamvil, MD, PhD | University of California, San Francisco |
Study Chair: | Emmanuelle Waubant, MD, PhD | University of California, San Francisco |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN020AI |
Study First Received: | October 14, 2004 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00094172 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Early Multiple Sclerosis MS Clinically Isolated Syndrome |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Atorvastatin Autoimmune Diseases of the Nervous System |
Antimetabolites Disease Immune System Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Nervous System Diseases Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses |