Treatment of Multiple Sclerosis Using Over the Counter Inosine

Completed · Phase 2

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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).

Key facts

Study ID

NCT00067327

Run by

National Center for Complementary and Integrative Health (NCCIH)

People needed

30

Starts

2002-02-01

Expected to finish

2005-09-01

Last updated by the study team

2006-03-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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