Treatment of Multiple Sclerosis Using Over the Counter Inosine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00067327 |
Recruitment Status :
Completed
First Posted : August 19, 2003
Last Update Posted : March 17, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis, Relapsing-Remitting | Drug: Inosine | Phase 2 |
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 |


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

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
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Douglas C Hooper, PhD | Thomas Jefferson University | |
Study Director: | Hilary Koprowski, MD | Department of Microbiology and Immunology, Thomas Jefferson University |
Publications:
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 |
Relapsing remitting multiple sclerosis Multiple sclerosis Peroxynitrite Uric acid Inosine |
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 |