Treatment of Multiple Sclerosis Using Over the Counter Inosine
Treatment of Multiple Sclerosis Using Over the Counter Inosine
What it found
The main measure was safety, drug levels or similar, not whether the treatment works.
“The only side-effect correlated with inosine treatment was kidney stone formation in 4/16 subjects.”Read by software from the paper's abstract
safety and tolerability of inosine in patients with relapsing-remitting multiple sclerosis · 1-year
| Group | n | Value |
|---|---|---|
| inosine | kidney stone formation in 4/16 subjects (as reported for the inosine-treated cohort) |
Total participants: 16
Read by software from the paper's abstract
What was tested
Treatment tested
- Inosine
Who could take part
Relapsing MS · 18 to 60
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
The treatment of multiple sclerosis with inosine.J Altern Complement Med · 2009
The only side-effect correlated with inosine treatment was kidney stone formation in 4/16 subjects.
Read by software from the paper's abstract
Background
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.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.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.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.
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History
Started
Feb 2002
Finished
Sept 2005