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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name