NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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 Recruiting
Health condition(s) or Problem(s) studiedParkinson's disease
Date of first enrollment22/03/2016
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeTime between the first administration of the drug to the onset of wearing off (19 item-Wearing-off questionnaire 2 or larger)
Secondary OutcomeTime 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
Age maximumNot applicable
GenderBoth
Include criteriaDiagnosed 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 criteriaA 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

Contact

Public contact
Name Masahiro Nagai
Address Shitsukawa 454, Toon, Ehime Ehime Japan 7910295
Telephone +81-899605095
E-mail 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
E-mail mnagai@m.ehime-u.ac.jp
Affiliation Ehime University Hospital