EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple Sclerosis

Completed · Phase 4

Conditions studied: Multiple Sclerosis

In brief

The purpose of this study is to determine the safety, tolerability and efficacy of a combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon beta-1a plus placebo in patients with clinically isolated syndrome suggestive of Multiple Sclerosis.

Key facts

Study ID: NCT00146068
Run by: University of North Carolina
People needed: 30
Starts: 2004-09-01
Expected to finish: 2007-12-01
Last updated by the study team: 2008-03-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has a diagnosis of CIS suggestive of MS involving optic nerve (unilateral optic neuritis), spinal cord (incomplete transverse myelitis), brain stem or cerebellum syndrome confirmed by ophthalmologic or neurological examinations. (Onset of CIS symptoms must occur within twelve months of randomization).
At baseline, subject will be between the ages of 18 and 60, inclusive.
Subject has a baseline EDSS score between 0.0 and 5.5, inclusive.
MRI findings on the brain scan should reveal at least three out the four following findings: one Gd-enhancing lesion or nine T2 hyperintense lesions; or at least one infratentorial lesion; or at least one juxtacortical lesion and or at least three periventricular lesions.
Subject has signed informed consent and HIPAA forms.

You may not qualify if…

Subject has a diagnosis of CD RRMS according to Poser criteria, definitive MS according McDonald criteria, secondary progressive, or primary progressive MS.
Subject has been treated with statins in the previous three months. Subject has history of severe side effects related to statin therapy.
Subject has had a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomization.
Subject has a history of, or abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, and/or other major disease.
Subject has a history of severe allergic or anaphylactic reactions or known drug hypersensitivity.
Subject has an abnormal screening blood test, performed at the screening visit, exceeding any of the limits defined below:
alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 times the upper limit of normal (1.5x ULN)
total white blood cell count < 2,300/mm\^3
CPK level > 2 x ULN on two consecutive occasions tested at least one week apart.
Platelets less than 150,00/mm3
Creatinine > 1.5mg/dl.
prothrombin time (PT) > ULN
Subject has history of treatment with either interferon-beta 1a or 1b, or glatiramer acetate.
Subject has had any prior treatment with any of the following medications:
total lymphoid irradiation
intravenous immunoglobulins IVIg, or plasma exchange
natalizumab or any other therapeutic monoclonal antibody
Subject has had treatment with any of the following medications within 1 year prior to randomization:
mitoxantrone
cyclophosphamide
Subject has had treatment with any of the following medications:
cyclosporine
azathioprine
methotrexate
glatiramer acetate

Where it is running

University of North Carolina-Chapel Hill MS clinic within the Neuroscience Hospital — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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