UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease
Title of the study (Brief title)	Analysis of caffeine absorption in 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 detect the differences of caffeine absorption between Parkinson's disease and control.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	concentration changes of caffeine and its metabolites (in serum of pre-administration and 0.5 h, 1 h, 2 h, 4 h and 6 h after administration of caffeine)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	PD group, 200 mg caffeine administration, qd, 1 day
Interventions/Control_2	Control group, 200 mg caffeine administration, qd, 1 day
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	40 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) 40-60 years old when the informed consent is obtained. 2) Clinical stage: Hoehn and Yahr I or II 3) After having sufficient explanation, he/she agreed with joining in this research with his/her own informed consent form.
Key exclusion criteria	1) >= 24 in Mini Mental State Examinations 2) Without heart disease, glaucoma or peptic ulcer. 3) Positive to past history of gasterointestinal surgery. 4) Presently having inflammatory bowel diseases, collagen vascular diseases, or bronchial asthma. 5) Having oral contraceptives. 6) Difficulty in withdraw caffeine intake just during 3 days before caffeine administration. 7) inappropriate cases who principle investigator identified.
Target sample size	20

Research contact person
Name of lead principal investigator	Nobutaka Hattori
Organization	Juntendo University
Division name	Department of Neurology
Address	2-1-1 Hongo Bunkyo
TEL	81-3-3813-3111
Email	nhattori@juntendo.ac.jp

Public contact
Name of contact person	Shinji Saiki
Organization	Juntendo University
Division name	Department of Neurology
Address	2-1-1
TEL	81-3-3813-3111
Homepage URL
Email	ssaiki@juntendo.ac.jp

Sponsor
Institute	Department of Neurology, Juntendo University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	順天堂大学医学部附属順天堂医院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 02 Day
Anticipated trial start date	2016 Year 05 Month 06 Day
Last follow-up date	2017 Year 03 Month 31 Day
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	2016 Year 05 Month 02 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025560