UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040768
Receipt number R000046496
Scientific Title New Narional Patient Registry for Duchenne muscular dystrophy (Remudy-DMD)
Date of disclosure of the study information 2020/06/15
Last modified on 2022/12/07 15:20:19

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Basic information

Public title

New Narional Patient Registry for Duchenne muscular dystrophy (Remudy-DMD)

Acronym

Remudy-DMD

Scientific Title

New Narional Patient Registry for Duchenne muscular dystrophy (Remudy-DMD)

Scientific Title:Acronym

Remudy-DMD

Region

Japan


Condition

Condition

Duchenne muscular dystrophy

Classification by specialty

Neurology Pediatrics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To create a national patient registry for Duchenne muscular dystrophy

Basic objectives2

Others

Basic objectives -Others

To collect clinical information of DMD patients in a sustained manner for a long time period, and to clarify the epidemiology of DMD, and to utilize the registry data for clinical development and post-market surveillance.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

none

Key secondary outcomes

1. Time to Stand Test (TTSTAND)
2. Time to Run/Walk 10 Meters test (TTRW)
3. Brooke Upper Extremity Scale
4. Ambulate or not
5. Ventilator use
6. Wheelchair use
7. Cardiac function
8. Respiratory function
9. Medication used
10. QOL
11. Adverse Events


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with a dystrophin abnormality proven by dystrophin gene testing or muscle pathology and a definitive diagnosis of DMD
2. Consent form for entry into the registry is available

Key exclusion criteria

1. Consent form for entry into the registry is not available
2. Determined by investigators to be ineligible to participate in this study

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Harumasa
Middle name
Last name Nakamura

Organization

National Center of Neurology and Psychiatry

Division name

Section of Clinical Research Support, Clinical Research and Education Promotion Division, National Center Hospital

Zip code

187-8551

Address

4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2711

Email

hnakamura@ncnp.go.jp


Public contact

Name of contact person

1st name Takami
Middle name
Last name Ishizuka

Organization

National Center of Neurology and Psychiatry

Division name

Section of Clinical Research Support, Clinical Research and Education Promotion Division

Zip code

187-8551

Address

4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan

TEL

042-341-2711

Homepage URL


Email

info-remudy-dmd@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Intramural Research Grant (2-4) for Neurological and Psychiatric Disorders of NCNP

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee, National Center of Neurology and Psychiatry

Address

4-1-1, Ogawa-higashi, Kodaira, Tokyo 187-8551, Japan

Tel

042-341-2711

Email

ml_rinrijimu@ncnp.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

国立精神・神経医療研究センター(東京都)、NHOあきた病院(秋田県)、NHO青森病院(青森県)、NHO大阪刀根山医療センター(大阪府)、NHO大牟田病院(福岡県)、NHO鈴鹿病院(三重県)、兵庫医科大学(兵庫県)、東京女子医科大学(東京都)、NHO東埼玉病院(埼玉県)、滋賀県立小児保健医療センター(滋賀県)、奈良県立医科大学(奈良県)、NHO熊本再春医療センター(熊本県)、岐阜大学医学部附属病院(岐阜県)、NHO医王病院(石川県)、NHO仙台西多賀病院(宮城県)、NHO長良医療センター(岐阜県)、NHOまつもと医療センター(長野県)、NHO箱根病院(神奈川県)、NHO西新潟中央病院(新潟県)、京都大学医学部附属病院(京都府)、倉敷成人病センター(岡山県)、倉敷成人病クリニック(岡山県)、山形大学(山形県)、NHO広島西医療センター(広島県)、鹿児島大学病院(鹿児島県)、楡の会こどもクリニック(北海道)、熊本大学病院(熊本県)、愛媛大学医学部附属病院(愛媛県)、秋田県立医療療育センター(秋田県)、国立成育医療研究センター(東京都)、群馬県立小児医療センター(群馬県)、安城更生病院(愛知県)、NHO新潟病院(新潟県)、長崎大学病院(長崎県)、東北大学病院(宮城県)、大館市立総合病院(秋田県)、宮城県立こども病院(宮城県)、NHO北海道医療センター(北海道)、筑波学園病院(茨城県)、青森県立はまなす医療教育センター(青森県)、順天堂大学医学部附属順天堂医院(東京都)、埼玉医科大学病院(埼玉県)、NHO徳島病院(徳島県)、愛知医科大学(愛知県)、名古屋市立大学医学部附属東部医療センター(愛知県)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 15 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

2020 Year 02 Month 03 Day

Date of IRB

2020 Year 03 Month 17 Day

Anticipated trial start date

2020 Year 06 Month 15 Day

Last follow-up date

2025 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 06 Month 15 Day

Last modified on

2022 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name