October 22, 1999
Summary: Media reports have been emerging regarding a study of oral (by mouth) interferon alpha for relapsing-remitting MS being conducted by investigators at the University of Texas Health Science Center in Houston:
- No official or published accounts of the results of this study are currently available, but according to media reports, results are promising, indicating the possibility that larger-scale clinical trials are warranted.
- 30 individuals with early relapsing-remitting MS are being studied, 1/3 on placebo and 1/3 on each of two different doses of drug, taken every other day.
- All subjects are being followed for nine months, with monthly magnetic resonance imaging and other assessments, to determine if treatment may result in reduction of MRI-detected lesions in the brain.
Details: There have been recent reports in the media concerning the ongoing, preliminary clinical trial of an oral (taken by mouth) form of interferon alpha for multiple sclerosis. Interferon alpha differs from the two interferon beta products (Avonex and Betaseron) that are currently available for relapsing forms of MS. This study is being conducted by Staley Brod, MD, and colleagues in the Department of Neurology at the University of Texas Health Sciences Center in Houston, with financial support from the National Institutes of Health.
Published results of this trial are not yet available. This study is being conducted to determine if use of oral interferon can result in a reduction of lesions detected in the brain by enhanced magnetic resonance imaging (MRI), as a first indication of possible benefit. According to media accounts, MRI data from the study appear to be showing positive trends.
A total of 30 individuals with early relapsing-remitting MS are being studied. Ten people are taking oral placebo every other day over nine months; the remaining twenty people are receiving one of two doses of oral interferon alpha, every other day.
The study involves nine months of monthly MRI scans as well as standard neurological and safety assessments. The primary question to be addressed, at this stage, is the safety and effect of treatment on numbers of enhancing MRI lesions in the brain. Because this pilot study involves so few people, any positive results will have to be confirmed in large-scale clinical trials before it will be known whether oral interferon alpha is a safe and effective treatment for MS.
This is the first study attempting to demonstrate in prospective, controlled clinical studies, the possible benefit and safety of an oral form of interferon alpha for relapsing-remitting MS. When more information is available on the outcomes of this pilot clinical trial, we will make it available.