UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of maintaining a serum urate level between 6.0 mg/dL and 7.5 mg/dL by the use of oral inosine in retarding the progress of Parkinson's disease which is defined as the advent of wearing off in patients with early stage Parkinson's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Time between the first administration of the drug to the onset of wearing off (19 item-Wearing-off questionnaire > 2)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years
Interventions/Control_2	Lactose as a placebo for 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosed as having Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria. 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.
Key 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)
Target sample size	100

Research contact person
Name of lead principal investigator	Masahiro Nomoto
Organization	Ehime University Graduate School of Medicine
Division name	Department of Neurology and Clinical Pharmacology
Address	Shizugawa 454, Toon City, Ehime, Japan 791-0295
TEL	089-960-5095
Email	nomoto@m.ehime-u.ac.jp

Public contact
Name of contact person	Hirotaka Iwaki
Organization	Ehime University Graduate School of Medicine
Division name	Department of Neurology and Clinical Pharmacology
Address	Shizugawa 454, Toon City, Ehime, Japan 791-0295
TEL	089-960-5095
Homepage URL
Email	h-iwaki@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ehime University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	愛媛大学医学部附属病院（愛媛県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 10 Month 26 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 12 Day
Last modified on	2016 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023631