UMIN-CTR Clinical Trial

Basic information
Public title	A Study to investigate the influence of diet on plasma levodopa concentration during LCIG therapy
Acronym	Influence of diet on LCIG therapy
Scientific Title	A Study to investigate the influence of diet on plasma levodopa concentration during LCIG therapy
Scientific Title:Acronym	Influence of diet on LCIG therapy
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the influence of lunch intake on plasma levodopa concentration and clinical symptoms during LCIG therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma levodopa concentration with or without lunch (including 20-25 g of protein)
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	Food
Interventions/Control_1	with or without lunch
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	Patients with Parkinson's disease who undergo LCIG therapy
Key exclusion criteria	Patients who have difficulty showing consent
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yuko Middle name Last name Hosokawa
Organization	Ehime University Hospital
Division name	Department of Neurology and Clinical Pharmacology
Zip code	791-0295
Address	454, shitsukawa Tohon, Ehime, Japan
TEL	089-960-5095
Email	hosokawa.yuko.ks@ehime-u.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Hosokawa
Organization	Ehime University Hospital
Division name	Department of Neurology and Clinical Pharmacology
Zip code	791-0295
Address	454, shitsukawa Tohon, Ehime, Japan
TEL	089-960-5095
Homepage URL
Email	hosokawa.yuko.ks@ehime-u.ac.jp

Sponsor
Institute	Department of Neurology and Clinical Pharmacology, Ehime University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saiseikai Matsuyama Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board ,Ehime University Hospital
Address	Tohon, Ehime, Japan
Tel	089-960-5914
Email	rinri@m.ehime-u.ac.jp

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 07 Month 16 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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 11 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 16 Day
Last modified on	2019 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042626