UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003149 |
|---|---|
| Receipt number | 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 | 2020/04/27 07:42:26 |
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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)
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
hamano@u-fukui.ac.jp
Sponsor or person
Institute
Tadanori Hamano
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003822
