UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019090 |
|---|---|
| Receipt number | R000022073 |
| Scientific Title | Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2017/01/25 16:59:13 |
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Basic information
Public title
Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water
Acronym
Dose finding test of reduced form of Coenzyme Q10 for Parkinson's disease
Scientific Title
Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water
Scientific Title:Acronym
Dose finding test of reduced form of Coenzyme Q10 for Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dose finding test of Coenzyme Q10 and combination study of hydrogen water
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences from baseline to 16th week of MDS-UPDRS part III and plasma % coenzyme Q10(CoQ10)
Key secondary outcomes
The differences of each parts or total of MDS-UPDRS
The differences of urine 18OH-dG
The differences of plasma reduced form of CoQ10
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
reduced form of CoQ10 300mg 16weeks
Interventions/Control_2
reduced form of CoQ10 600mg 16weeks
Interventions/Control_3
reduced form of CoQ10 600mg 16weeks
hydrogen water 500ml(Suisosui 7.0) 16weeks
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
diagnosed as PD conforming to the United Kingdom Brain Bank criteria
treated with levodopa
the same anti-parkinsonian drug regimen for at least 8 weeks prior to baseline assessment
modified Hoehn and Yahr stage 1~3
twenty to eighty years old
without dementia
written informed consent was obtained
Key exclusion criteria
presence of parkinsonism unrelated to PD, dementia or other serious disease, malignant tumor, a history of brain surgery, and adverse events caused by medications.
modified Hoehn and Yahr stage 4 and 5
without allergy for medication
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Juntendo University Koshigaya Hospital
Division name
Neurology
Zip code
Address
Fukuroyama 560, Koshigaya-shi, Saitama Japan
TEL
048-975-0321
ayori@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Yoritaka |
Organization
Neurology
Division name
Juntendo University Koshigaya Hospital
Zip code
Address
Fukuroyama 560, Koshigaya-shi, Saitama Japan
TEL
048-975-0321
Homepage URL
ayori@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Juntendo University Koshigaya Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 11 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | 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
| 2015 | Year | 09 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022073
| 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 |
