Status:
COMPLETED
Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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...
Detailed Description
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; a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- History of severe depression or suicidal ideation within 1 year of study entry
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00094172
Start Date
May 1 2005
End Date
May 1 2009
Last Update
April 28 2017
Active Locations (14)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Keck School of Medicine
Los Angeles, California, United States, 90033
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Yale MS Research Center
New Haven, Connecticut, United States, 06510