Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease
Phase 2
Recruiting
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-UMIN000020527
- Lead Sponsor
- Ehime University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time between the first administration of the drug to the onset of wearing off (19 item-Wearing-off questionnaire > 2)
- Secondary Outcome Measures
Name Time Method Time taken to reach Hoehn&Yahr 3.0 or above Score change in UPDRS Medication of levodopa over 300 Change in SBR in DATSCAN Change in H/M in MIBG