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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00067327 |
The purpose of this study is to determine whether raising low levels of the natural antioxidant uric acid by the administration of a precursor, inosine, has any therapeutic effect on the progression of Relapsing Remitting Multiple Sclerosis (RRMS) and secondary progressive Multiple Sclerosis (MS).
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Inosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Multiple Sclerosis Using Over the Counter Inosine |
Estimated Enrollment: | 30 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | September 2005 |
Uric acid is a natural inhibitor of certain chemistries associated with peroxynitrite, a product of inflammation. In animal models of multiple sclerosis (MS), these chemical reactions have been associated with breakdown of the blood-brain barrier and CNS tissue damage. In addition, MS patients have serum uric acid levels that are lower than age- and sex- matched healthy individuals. The primary purpose of this study to determine whether raising low serum uric acid levels by daily oral administration of its precursor inosine has an effect on the cumulative number of newly active lesions on magnetic resonance imaging (MRI) and to evaluate the safety and tolerability of inosine in patients diagnosed with relapsing remitting and secondary progressive MS.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Douglas C Hooper, PhD | Thomas Jefferson University |
Study Director: | Hilary Koprowski, MD | Department of Microbiology and Immunology, Thomas Jefferson University |
Study ID Numbers: | R21 AT001301-01A1 |
Study First Received: | August 15, 2003 |
Last Updated: | March 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00067327 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapsing remitting multiple sclerosis Multiple sclerosis Peroxynitrite Uric acid Inosine |
Uric Acid Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases |
Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |