Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Atorvastatin; Placebo
Intervention description: 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; tablet form
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Early Multiple Sclerosis; MS; Clinically Isolated Syndrome

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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