UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water
Title of the study (Brief title)	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	Asako Yoritaka
Organization	Juntendo University Koshigaya Hospital
Division name	Neurology
Address	Fukuroyama 560, Koshigaya-shi, Saitama Japan
TEL	048-975-0321
Email	ayori@juntendo.ac.jp

Public contact
Name of contact person	Asako Yoritaka
Organization	Neurology
Division name	Juntendo University Koshigaya Hospital
Address	Fukuroyama 560, Koshigaya-shi, Saitama Japan
TEL	048-975-0321
Homepage URL
Email	ayori@juntendo.ac.jp

Sponsor
Institute	Juntendo University Koshigaya Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022073