Safety/Effectiveness of Adding Monthly Dexamethasone to Weekly Avonex for MS

Completed

Conditions studied: Relapsing-remitting Multiple Sclerosis, Clinically Isolated Syndrome

In brief

The purpose of the study is to determine whether giving intravenous dexamethasone every 4 weeks during the first 12 months of weekly Avonex dosing will reduce the progression of functional impairment, brain atrophy, relapse rate and frequency, and new and enlarging brain lesions over the first 24 months of Avonex therapy in patients with relapsing-remitting or mono-symptomatic multiple sclerosis.

Key facts

Study ID

NCT00232193

Run by

Providence Multiple Sclerosis Center

People needed

40

Starts

2003-12-01

Expected to finish

2010-08-01

Last updated by the study team

2011-07-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and female patients between the ages of 18-55 years inclusive
• have provided informed consent to be screened for the study
• have been diagnoses as having MS
• meet the McDonald diagnostic criteria for RRMS or CHAMPS criteria for CIS
• have an EDSS score of 0.0-3.5
• have had no immunomodulator or cytoxic agents and have had no steroids or other immunosuppressants within 30 days prior to Baseline Visit
• must have had a brain MRI scan demonstrating lesions consistent with MS on T2-weighted or FLAIR images
• subjects must be willing and able to participate in all aspects of the study, including use of study medications as prescribed, and screening and follow-up clinical and MRI assessments

You may not qualify if…

• type I of type II diabetes
• uncontrolled hypertension (systolic >160 or diastolic >100 despite medication therapy)
• history of suicidal ideation
• history of psychosis
• history of alcoholism or other substance abuse
• clinically significant coronary artery disease
• history of hepatic failure and chronic renal failure
• history of cancer other than basal or squamous cell carcinoma of the skin
• pregnancy or unwillingness to use adequate precautions to prevent pregnancy during the duration of this study
• nursing mothers
• history of stroke, dementia, seizure disorder, peripheral neuropathy, Parkinsonism, myasthenia, myelopathy or other primary degenerative disease of the central or peripheral nervous system
• history of peptic ulcer disease
• history of intolerance to corticosteroids or allergy to albumin
• history of osteoporosis
• history of Lupus, Sjogrens syndrome, Lyme disease or syphilis
• abnormal laboratory results indicative of significant hepatic, renal, hematopoetic, or coagulation dysfunction
• the entity of any disease entity, which in the opinion of the investigators would potentially prevent the patient from successfully completing 2 years participation in this trial or confound the observations made during this trial
• prior use of Avonex, Betaseron, Rebif, mitoxantrone, cyclophosphamide, azothioprine, methotrexate, cladribine, cyclosporin, CellCept, IVIG, natalizumab, anti T-cell or anti B-cell antibodies, plasmapheresis or other systemic immunosuppressant or cancer chemotherapeutic agents
• unwillingness or inability to comply with all the requirements of the protocol
• known diagnosis of osteoporosis

Where it is running

• Providence MS Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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