Treatment of Multiple Sclerosis Using Over the Counter Inosine

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00067327
First received: August 15, 2003
Last updated: March 16, 2006
Last verified: March 2006
  Purpose

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
Multiple Sclerosis, Relapsing-Remitting
Drug: Inosine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Multiple Sclerosis Using Over the Counter Inosine

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 30
Study Start Date: February 2002
Estimated Study Completion Date: September 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067327

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Douglas C Hooper, PhD Thomas Jefferson University
Study Director: Hilary Koprowski, MD Department of Microbiology and Immunology, Thomas Jefferson University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00067327     History of Changes
Other Study ID Numbers: R21 AT001301-01A1
Study First Received: August 15, 2003
Last Updated: March 16, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Relapsing remitting multiple sclerosis
Multiple sclerosis
Peroxynitrite
Uric acid
Inosine

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014