UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of CDP-choline for the patients with corticobasal degeneration
Acronym	CDP-choline treatment for CBD patients
Scientific Title	Clinical trial of CDP-choline for the patients with corticobasal degeneration
Scientific Title:Acronym	CDP-choline treatment for CBD patients
Region	Japan

Condition
Condition	coticobasal degeneration
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Corticobasal degeneration (CBD) is a neurodegenarative disorder of cerebral cortex and basal ganglia. No effective treatment for CBD is developed, yet. CDP-choline is a key intermediate metabolite in the biosynthesis of phosphatidyl choline. We explore the effectiveness of CDP-choline for CBD patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Neurological Examinations (clumsieness of upper limbs, and gait disturbances) Unified Parkinson's Rating Scale (UPDRS) FIM, MMSE
Key secondary outcomes	FDG-PET findings

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	Factor A(-), Factor A (-)
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	50 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	The patients meet the clinical criteria of corticobasal degeneration by Japan Intractable Disease Information Center
Key exclusion criteria	The patients who showed allergy by previous CDP-choline injection.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tadanori Hamano
Organization	University of Fukui
Division name	Second Department of Internal Medicine
Zip code
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL	0776-61-3111(2300)
Email

Public contact
Name of contact person	1st name Middle name Last name Tadanori Hamano
Organization	University of Fukui
Division name	Second Department of Internal Medicine
Zip code
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193 Japan
TEL	0776-61-3111(2300)
Homepage URL
Email	hamano@u-fukui.ac.jp

Sponsor
Institute	Tadanori Hamano
Institute
Department

Funding Source
Organization	University of Fukui
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	福井大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 08 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	No longer recruiting
Date of protocol fixation	2008 Year 10 Month 20 Day
Date of IRB	2008 Year 10 Month 20 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 02 Month 08 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003822