Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease

Phase 2

Completed

• Conditions: Parkinson's disease; D010300

• Registration Number: JPRN-jRCTs061180060
• Lead Sponsor: agai Masahiro

Brief Summary

Inosine was tolerable and it effectively increased the plasma level of urate but we did not observed a protective effect on the progression of Parkinson's disease

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2022-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

Inclusion 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.

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 <br>(19 item-Wearing-off questionnaire 2 or larger)

Secondary Outcome Measures

Name	Time	Method
Time taken to reach Hoehn&Yahr 3.0 or above <br>Score change in UPDRS <br>Medication of levodopa over 450 <br>Change in SBR in DATSCAN <br>Change in H/M in MIBG