UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009062 |
|---|---|
| Receipt number | R000010637 |
| Scientific Title | An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2016/08/03 09:13:58 |
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Basic information
Public title
An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease
Acronym
An evaluation of the safety of inosine for patients with Parkinson's disease
Scientific Title
An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease
Scientific Title:Acronym
An evaluation of the safety of 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 evaluate the safety and tolerability of maintaining a serum UA level between 6.0 and 8.0 mg/dL for one year by using oral inosine
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The safety of using inosine to elevate serum UA level
Key secondary outcomes
The degree to which the serum UA level can be increased
The capacity to maintain a target range UA level
The change in UPDRS/Yahr
The period before starting/increasing L-dopa
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dL
Interventions/Control_2
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 with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria
* Baseline serum UA below 5.5(male) or 4.2 (female)
* Age 20 or older at the time of enrolment
Key exclusion criteria
* History of kidney stones, gout (or other arthritis), or ischemic heart diseases
* History of any kidney diseases or baseline eGFR below 60 (mL/min/1.73 m2)
* Acidic urine (pH<5.0), uric acid or uric salt crystal in urine test
* Blood pressure >160/80 mmHg or unstable hypertension
* Use of certain medication including
diuretics, losartan, antituberculosis drugs, or immune suppressors
* Use of daily NSAIDs
* Woman who are pregnant or lactating
* Other inadequate status for clinical trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University
Division name
Dept. of Clinical pharmacology and Neurology
Zip code
Address
454 Shitsukawa, Toon, Ehime 791-0295 Japan
TEL
+81-89-960-5095
h-iwaki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotaka Iwaki |
Organization
Ehime University
Division name
Dept. of Clinical pharmacology and Neurology
Zip code
Address
Toon City 454, Ehime
TEL
089-960-5095
Homepage URL
h-iwaki@m.ehime-u.ac.jp
Sponsor or person
Institute
Dept. of Clinical pharmacology and Neurology
Institute
Department
Personal name
Funding Source
Organization
Ehime University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 08 | 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=R000010637
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
