Status:
COMPLETED
EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif) and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome suggestive o...
Detailed Description
Multiple Sclerosis (MS) is a chronic neurologic disease, characterized pathologically by focal areas of inflammation, demyelination, axonal injury and degeneration in the central nervous system. MS fo...
Eligibility Criteria
Inclusion
- Patients with isolated clinical syndrome suggestive of MS
- At least three out of four magnetic resonance imaging (MRI) findings on the initial scan:
- One Gd-enhancing lesion or nine T2 hyperintense lesions;
- At least one infratentorial lesion;
- At least one juxtacortical lesion; and
- At least three periventricular lesions.
- Expanded Disability Status Scale (EDSS) 0-5.5
- 18 to 60 years of age
- At least one relapse in previous 12 months
Exclusion
- Patients with a diagnosis of clinically definitive relapsing-remitting (RR) MS, secondary progressive, or primary progressive MS.
- Patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (TLI).
- Patients treated with IFNb-1a, IFNb-1b, glatiramer acetate, intravenous immunoglobulins (IVIg), plasma exchange, methotrexate, or azathioprine in the previous 3 months.
- Patients treated with intravenous or oral steroids within 30 days prior to baseline MRI.
- Patients who have been treated with statins in the previous 3 months.
- Pregnant or breast-feeding women.
- Patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease.
- Abnormal baseline blood tests including alanine transaminase (ALT) or aspartate transaminase (AST) greater than twice the upper limit of normal
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00137176
Start Date
October 1 2004
End Date
October 1 2008
Last Update
June 23 2009
Active Locations (1)
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1
University of North Carolina-Chapel Hill MS Clinic Within the Neuroscience Hospital
Chapel Hill, North Carolina, United States, 27599