Treatment of Multiple Sclerosis Using Over the Counter Inosine

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ClinicalTrials.gov Identifier: NCT00067327

Recruitment Status : Completed

First Posted : August 19, 2003

Last Update Posted : March 17, 2006

Sponsor:

Information provided by:

National Center for Complementary and Integrative Health (NCCIH)

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Inosine	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Treatment of Multiple Sclerosis Using Over the Counter Inosine
Study Start Date :	February 2002
Study Completion Date :	September 2005

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis Over-the-Counter Medicines

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Nonpregnant, nonlactating females
Females of child bearing potential must have a negative human chorionic gonadotropin (HCG) test result within 60 days before the first dose of study material.
Males and females must practice adequate contraception, in the judgement of the investigator, during the course of the study.
Subjects must have a diagnosis of clinically definite Relapsing Remitting Multiple Sclerosis based on medical history, physical examination, laboratory test results, and neurologic examination. Alternatively, subjects may have clinically probable MS characterized by 1 attack and the presence of at least 4 lesions on MRI within 12 months before the initial baseline evaluation.
Subjects must have an Expanded Disability Status Scale (EDSS) test result of less than or equal to 5.0 within 60 days before the first dose of study material.
Subjects will have serum uric acid levels less than 5 mg/dl.
Have 1 clinical relapse in the last year

Exclusion Criteria:

Presence of any medical disability or laboratory test result that, in the judgement of the investigator, would interfere with assessment of the tolerability, safety, or efficacy of study material or would compromise the subject's ability to provide informed consent.
Evidence of active infection characterized by requiring treatment with antibiotics within 7 days before the first dose of study material.
Treatment with interferons, glatiramer acetate, lymphoid irradiation, cyclophosphamide, or with other immune modifying treatments within 3 months, or corticosteroids within 1 month before the initial baseline MRI assessment in this trial.
Recent history (within the previous 2 years) of drug or alcohol abuse.
Known allergy to Inosine products or history of anaphylaxis.
Previous randomization into this study.
Treatment with an investigational agent within 30 days before the first dose of study material.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067327

Locations

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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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Principal Investigator:	Douglas C Hooper, PhD	Thomas Jefferson University
Study Director:	Hilary Koprowski, MD	Department of Microbiology and Immunology, Thomas Jefferson University

More Information

Publications:

Hooper DC, Spitsin S, Kean RB, Champion JM, Dickson GM, Chaudhry I, Koprowski H. Uric acid, a natural scavenger of peroxynitrite, in experimental allergic encephalomyelitis and multiple sclerosis. Proc Natl Acad Sci U S A. 1998 Jan 20;95(2):675-80.

Hooper DC, Scott GS, Zborek A, Mikheeva T, Kean RB, Koprowski H, Spitsin SV. Uric acid, a peroxynitrite scavenger, inhibits CNS inflammation, blood-CNS barrier permeability changes, and tissue damage in a mouse model of multiple sclerosis. FASEB J. 2000 Apr;14(5):691-8.

Koprowski H, Spitsin SV, Hooper DC. Prospects for the treatment of multiple sclerosis by raising serum levels of uric acid, a scavenger of peroxynitrite. Ann Neurol. 2001 Jan;49(1):139.

Spitsin S, Hooper DC, Leist T, Streletz LJ, Mikheeva T, Koprowskil H. Inactivation of peroxynitrite in multiple sclerosis patients after oral administration of inosine may suggest possible approaches to therapy of the disease. Mult Scler. 2001 Oct;7(5):313-9.

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ClinicalTrials.gov Identifier:	NCT00067327 History of Changes
Other Study ID Numbers:	R21AT001301-01A1 ( U.S. NIH Grant/Contract )
First Posted:	August 19, 2003 Key Record Dates
Last Update Posted:	March 17, 2006
Last Verified:	March 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):


Relapsing remitting multiple sclerosis Multiple sclerosis Peroxynitrite Uric acid Inosine

Additional relevant MeSH terms:

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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS	Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases

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