Treatment of Multiple Sclerosis Using Over the Counter Inosine

NCT00067327 | Completed Phase 2

• 1 other identifier: R21AT001301-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing remitting multiple sclerosis; Multiple sclerosis; Peroxynitrite; Uric acid; Inosine

Interventions

Inosine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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. doi: 10.1073/pnas.95.2.675.

  PMID: 9435251 BACKGROUND

• 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. doi: 10.1096/fasebj.14.5.691.

  PMID: 10744626 BACKGROUND

• 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. doi: 10.1002/1531-8249(200101)49:13.0.co;2-a. No abstract available.

  PMID: 11198290 BACKGROUND

• 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. doi: 10.1177/135245850100700507.

  PMID: 11724447 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Inosine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Douglas C Hooper, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Hilary Koprowski, MD

  Department of Microbiology and Immunology, Thomas Jefferson University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 15, 2003
• First Posted: August 19, 2003
• Study Start: February 1, 2002
• Study Completion: September 1, 2005
• Last Updated: March 17, 2006

Record last verified: 2006-03

Locations

US (1)