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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020527
Receipt No. R000023631
Scientific Title 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
Date of disclosure of the study information 2016/02/01
Last modified on 2016/08/03

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Basic information
Public title 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
Acronym Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Masahiro Nomoto
Organization Ehime University Graduate School of Medicine
Division name Department of Neurology and Clinical Pharmacology
Zip code
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
1st name
Middle name
Last name Hirotaka Iwaki
Organization Ehime University Graduate School of Medicine
Division name Department of Neurology and Clinical Pharmacology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2015 Year 10 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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