JRCT ID: jRCTs061180060
Registered date:18/03/2019
Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Parkinson's disease |
Date of first enrollment | 22/03/2016 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP) |
Outcome(s)
Primary Outcome | Time between the first administration of the drug to the onset of wearing off (19 item-Wearing-off questionnaire 2 or larger) |
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Secondary Outcome | Time taken to reach Hoehn&Yahr 3.0 or above Score change in UPDRS Medication of levodopa over 450 Change in SBR in DATSCAN Change in H/M in MIBG |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Diagnosed as having Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria. Confirmed negative for vascular Parkinsonism by Brain CT/MRI within one year Within 5 years (60 months) from the start of any anti-Parkinsonism medication. 19 item-Wearing-off questionnaire <= 1 at the time of the screening visit and Visit 1. Serum urate level <= 5.5 mg/dL in male or <= 4.2 mg/dL in female. Age >=20 and obtained written informed consent. |
Exclude criteria | A history of kidney stones, gout(or chronic arthritis), ischemic heart disease A history of kidney failure of eGFR <= 60 at the screening visit. Having uncontrolled hypertension which is defined as SBP>=160 or DBP >=100 Current treatment with medication which slows urate excretion, which is defined as taking diuretics, losartan, anti-tuberculosis drugs or immune-suppression agents. Being pregnant or having an intention to become pregnant during the study period. Other factors that investigators deem inappropriate to enroll for the trial. (e.g. Having malignancy, arthritis which is difficult to discern from gout, severe allergic history to drugs) |
Related Information
Primary Sponsor | Nagai Masahiro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000020527 |
Contact
Public contact | |
Name | Masahiro Nagai |
Address | Shitsukawa 454, Toon, Ehime Ehime Japan 7910295 |
Telephone | +81-899605095 |
mnagai@m.ehime-u.ac.jp | |
Affiliation | Ehime University Hospital |
Scientific contact | |
Name | Masahiro Nagai |
Address | Shitsukawa 454, Toon, Ehime Ehime Japan 7910295 |
Telephone | +81-899605095 |
mnagai@m.ehime-u.ac.jp | |
Affiliation | Ehime University Hospital |