Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
STAYCIS
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 (ITN020AI)
1 other identifier
interventional
82
2 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-sclerosis
Started May 2005
Typical duration for phase_2 multiple-sclerosis
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2004
CompletedFirst Posted
Study publicly available on registry
October 15, 2004
CompletedStudy Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
November 3, 2011
CompletedApril 28, 2017
March 1, 2017
4 years
October 14, 2004
September 29, 2011
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.
The occurrence of ≥ T2 lesions\[1\] with or without gadolinium lesion (Gd+) enhancement\[2\] or clinical exacerbation\[3\] through 12 months. A higher score indicates more severe disease 1. A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan 2. A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion 3. A clinical exacerbation is a new neurological symptom that lasts more than 48 hours in a participant who has been neurologically stable for 30 days following start of study medication
12 months post-randomization
Secondary Outcomes (2)
Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria
12 months post-randomization
Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria
18 months post-randomization
Study Arms (2)
Atorvastatin
EXPERIMENTAL80 mg/day
Placebo
PLACEBO COMPARATOROnce daily.
Interventions
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
Eligibility Criteria
You may qualify if:
- Clinically isolated syndrome (CIS) as defined by an acute or subacute well-defined neurological event lasting at least 48 hours and consistent with MS (i.e., optic neuritis, spinal cord syndrome, brainstem/cerebellar syndromes). Other causes for optic neuritis other than CIS must be ruled out by an ophthalmologist. Patients with other "clinically silent" abnormal findings found upon neurological examination that are not attributable to the presenting symptom are not excluded.
- Onset of CIS symptoms occurring within 90 days of randomization
- Abnormal, unenhanced brain MRI with 2 or more clinically silent T2 lesions greater than or equal to 3 mm in diameter, at least one of which is periventricular in location or ovoid in shape
- Willing to use acceptable methods of contraception
- Have received 3 to 5 days of corticosteroid therapy within 60 days of CIS onset
You may not qualify if:
- Definite diagnosis of MS according to McDonald criteria
- Previous history of neurological symptoms lasting more than 48 hours. Patients with a history of neurological symptoms lasting less than 48 hours will not be excluded.
- Prior use of interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis anytime prior to study entry
- Use of interferon preparations (unless as specified by the protocol), glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis during the study
- Use of cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungal during the study
- Received more than 5 g of methylprednisolone (or the equivalent of other IV corticosteroid) prior to study screening
- Use of a cholesterol-lowering agent during the 3 months prior to study screening or need for such agents during the study
- Previous history of severe side effects with statin therapy
- Prior exposure to total lymphoid irradiation
- History of substance abuse in the 12 months prior to study screening
- History of systemic illness or medical condition that would limit the likelihood of completing the MRI procedures or would interfere with the measurement of a therapeutic effect
- Implanted pacemakers, cochlear implants, defibrillators, or metallic objects on or inside the body
- Uncontrolled hypertension, asthma, known malignancy other than skin cancer, symptomatic cardiac disease, epilepsy, insulin-dependent diabetes, or symptoms that can only be explained by systemic lupus erythematosus (SLE) or other autoimmune diseases
- Active liver disease
- Major medical illnesses or psychiatric impairment that in the investigator's opinion could interfere with the study
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Keck School of Medicine
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Yale MS Research Center
New Haven, Connecticut, 06510, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Washington University Multiple Sclerosis Center
St Louis, Missouri, 63110, United States
Jacobs Neurological Institute
Buffalo, New York, 14203, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14642, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75930, United States
Virginia Mason MS Center
Seattle, Washington, 98111, United States
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4, Canada
Related Publications (1)
Waubant E, Pelletier D, Mass M, Cohen JA, Kita M, Cross A, Bar-Or A, Vollmer T, Racke M, Stuve O, Schwid S, Goodman A, Kachuck N, Preiningerova J, Weinstock-Guttman B, Calabresi PA, Miller A, Mokhtarani M, Ikle D, Murphy S, Kopetskie H, Ding L, Rosenberg E, Spencer C, Zamvil SS; ITN STAyCIS Study Group; ITN020AI Study Management Team. Randomized controlled trial of atorvastatin in clinically isolated syndrome: the STAyCIS study. Neurology. 2012 Apr 10;78(15):1171-8. doi: 10.1212/WNL.0b013e31824f7fdd. Epub 2012 Mar 28.
PMID: 22459680RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Scott Zamvil, MD, PhD
University of California, San Francisco
- STUDY CHAIR
Emmanuelle Waubant, MD, PhD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2004
First Posted
October 15, 2004
Study Start
May 1, 2005
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
April 28, 2017
Results First Posted
November 3, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Data access is provided to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools available to researchers; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials available to the public.