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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003149
Receipt No. R000003822
Scientific Title Clinical trial of CDP-choline for the patients with corticobasal degeneration
Date of disclosure of the study information 2010/02/08
Last modified on 2014/05/02

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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 Open public recruiting
Date of protocol fixation
2008 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
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
2014 Year 05 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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