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Home > "T" Clinical Trials Conditions > Treatment of Multiple Sclerosis using Over the Counter Inosine  Treatment of Multiple Sclerosis using Over the Counter Inosine
Treatment of Multiple Sclerosis using Over the Counter Inosine
For Condition: Multiple Sclerosis, Relapsing-Remitting
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
ClydeMarkowitz, Principal Investigator, University of Pennsylvania
Hospital of the University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Tara Ordille 215-662-4893
Additional Information:
Study ID Numbers: R21 AT001301-01A1;
Study Start Date: February 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067327
Other Multiple Sclerosis, Relapsing-Remitting Studies:
1. A Phase II Study Comparing Low- and High-Dose CAMPATH and High-Dose Rebif in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
2. Treatment of Multiple Sclerosis using Over the Counter Inosine
3. Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
4. Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis
5. Safety of RG2077 in Patients With Multiple Sclerosis
Related Studies:
Other Multiple Sclerosis, Relapsing-Remitting Clinical Trials
Other Pennsylvania Clinical Trials
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Treatment of Multiple Sclerosis using Over the Counter Inosine
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