UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030930 |
|---|---|
| Receipt number | R000035328 |
| Scientific Title | Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/12/17 16:59:42 |
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Basic information
Public title
Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease.
Acronym
Effect of febuxostat and inosine on Parkinson's disease
Scientific Title
Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease.
Scientific Title:Acronym
Effect of febuxostat and inosine on Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine efficacy and safety of simultaneous administration of febuxostat and inosine for patients with Parkinson's disease for 8 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of MDS-UPDRS Part III score before registration and after 57 days of the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of febuxostat 20 mg and inosine 500 mg twice a day for 58 days
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese patient who gave voluntary written consent with regard to study participation
2. Patient with 20 to 80 years of age
3. Gender: male or female
4. Patient who has been diagnosed with Parkinson's disease and fulfill all the following criteria,
Hoehn-Yahr scale stage 1-3
MDS-UPDRS Part III score not less than 15
MMSE score not less than 24
Key exclusion criteria
(1) Patient who requires nearly full assistance in one's daily life, is incapable of walking and standing
(2) Patient taking azathioprine, mercaptopurine hydrate, vidarabine or didanosine
(3) Patient whose serum creatinine exceeds 1.5 times the upper limit of the reference value or whose AST (GOT) or ALT (GPT) exceeds the upper limit of the reference value in the pre-registration examination
(4) Patient who has undergone surgical treatment for Parkinson's disease
(5) Patient with a history or a current illness of gout, hyperuricaemia or urolithiasis
(6) Patient who has been treated with febuxostat
(7) Patient who has a history or a present illness of hypersensitivity / Idiosyncratic reaction (allergy) to a drug or drugs
(8) Patient who has used an investigational drug within 30 days before the consent
(9) Patient with pregnancy or a possibility of pregnancy, or lactating patient
(10) Patient judged inappropriate with other reasons by a principal investigator or a subinvestigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Gen |
| Middle name | |
| Last name | Sobue |
Organization
Nagoya University Graduate School of Medicine
Division name
Brain and Mind Research Center
Zip code
466-8560
Address
Tsurumai-machi 65, Showa-ku, Nagoya, Aichi
TEL
052-741-2111
sobueg@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Kamatani |
Organization
StaGen Co. Ltd.
Division name
Research Institute for Artificial Intelligence in Medicine
Zip code
111-0051
Address
KUGA Bldg 8F, 4-11-6 Kuramae, Taito-ku, Tokyo
TEL
03-5835-2137
Homepage URL
kamatani@msb.biglobe.ne.jp
Sponsor or person
Institute
StaGen Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
StaGen Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Human Rights and Ethics for Clinical Studies
Address
Ichibancho 13-2, Chiyoda-ku, Tokyo
Tel
03-5213-0028
secretariat@hurecs.org
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
| 2019 | Year | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035328
