UMIN-CTR Clinical Trial

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

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name

Organization

Ehime University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

愛媛大学医学部附属病院（愛媛県）

Date of disclosure of the study information

2016

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

01

Month

12

Day

Last modified on

2016

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023631