At a glance
ClinicalIndex Comparison Record- ✓Clinically isolated syndrome (CIS) defined by acute neurological event lasting ≥48 hours consistent with MS (optic neuritis, spinal cord syndrome, brainstem/cerebellar syndromes)
- ✓CIS symptom onset within 90 days of randomization
- ✓Abnormal, unenhanced brain MRI with ≥2 clinically silent T2 lesions ≥3 mm in diameter, at least one periventricular or ovoid in shape
- ✓Received 3-5 days of corticosteroid therapy within 60 days of CIS onset
- ✕Definite diagnosis of MS according to McDonald criteria
- ✕Prior use of interferon, glatiramer acetate, cyclophosphamide, mitoxantrone, or plasmapheresis
- ✕Prior exposure to statins or cholesterol-lowering agents within 3 months of screening
- ✕History of severe side effects with statin therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Atorvastatin and Placebo for Multiple Sclerosis. Completed, enrolled 82 participants across 14 sites in 2 countries.
Detailed 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.
Study Details
Timeline
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
tablet form