UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014250 |
|---|---|
| Receipt number | R000016600 |
| Scientific Title | evaluation of CNS in muscular dystrophy |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2019/03/12 22:02:34 |
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Basic information
Public title
evaluation of CNS in muscular dystrophy
Acronym
evaluation of CNS in muscular dystrophy
Scientific Title
evaluation of CNS in muscular dystrophy
Scientific Title:Acronym
evaluation of CNS in muscular dystrophy
Region
| Japan |
Condition
Condition
Muscle dystrophy
Classification by specialty
| Neurology | Pediatrics | Radiology |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A morphological and functional evaluation of the central nerve of patients with muscular dystrophy
Basic objectives2
Others
Basic objectives -Others
Confirmation of the abnormal distribution of the GABA receptor using iomazenil SPECT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We confirm a function and morphological abnormal presence
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Iomazenile SPECT/MRI/PET/EEG/clinical examination
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
The patients with muscular dystrophy
Key exclusion criteria
The person that an examination for 30-minute imaging is impossible
exclude the patients who are recognized as inadequate patients by doctors with responsibility in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Nakada |
Organization
University of Niigata,
Brain Research Institute
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimachi 1-757, Chuo-ku,Niigata
TEL
025-227-0683
tnakada@bri.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Suzuki |
Organization
University of Niigata, Brain Research Institute
Division name
Center for Integrated Human Brain Science
Zip code
951-8585
Address
Asahimachi 1-757, Chuo-ku,Niigata
TEL
025-227-0683
Homepage URL
yuji-s@bri.niigata-u.ac.jp
Sponsor or person
Institute
Center for Integrated Human Brain Science, Brain Research Institute, University of Niigata
Institute
Department
Personal name
Funding Source
Organization
grant from Ministry of Education, Culture, Sports, Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization, Niigata National Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata National Hospital
Address
3-52 Akasaka-cho Kashiwazaki, Niigata
Tel
0257-22-2126
225sy01@hosp.go.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
国立病院機構新潟病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016600
