UMIN-CTR Clinical Trial

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
Last 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
Email	tnakada@bri.niigata-u.ac.jp

Public contact
1st 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
Email	yuji-s@bri.niigata-u.ac.jp

Sponsor
Institute	Center for Integrated Human Brain Science, Brain Research Institute, University of Niigata
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016600