UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030626
Receipt number R000034969
Scientific Title Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Date of disclosure of the study information 2017/12/28
Last modified on 2018/03/15 10:49:28

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Basic information

Public title

Investigation on the effectiveness of histidine copper treatment of Menkes disease patients

Acronym

Investigation on the effectiveness of histidine copper treatment of Menkes disease patients

Scientific Title

Investigation on the effectiveness of histidine copper treatment of Menkes disease patients

Scientific Title:Acronym

Investigation on the effectiveness of histidine copper treatment of Menkes disease patients

Region

Japan


Condition

Condition

Menkes disease

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effect of histidine copper treatment in Menkes' disease patients is said to be different depending on the timing of treatment start and gene mutation. The purpose of this study is to clarify the effect of histidine copper on each symptom of Menkes' disease patients participating in the study. In addition, we aim to contribute to the treatment of subjects and other Menkes' disease patients by clarifying that copper deficiency is prevented / improved by histidine copper administration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

development

Key secondary outcomes

The presence or absence of spasm


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

Weekly,subcutaneous injection of histidine copper (750microgram once) is performed three times per week.It is continued every week until the end of the research during the research period.

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

Those who have written explanation and consent from patients who want family history of histidine copper treatment in Menkes disease patients

Key exclusion criteria

None

Target sample size

2


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tokiko Fukuda

Organization

Hamamatsu University School of Medicine

Division name

Department of Pediatrics

Zip code


Address

1-20-1 Hamdayama,Higashi-ku,Hamamatsu-city,Shizuoka

TEL

053-435-2638

Email

toki-fkd@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tokiko Fukuda

Organization

Hamamatsu University School of Medicine

Division name

Department of Pediatrics

Zip code


Address

1-20-1 Hamdayama,Higashi-ku,Hamamatsu-city,Shizuoka

TEL

053-435-2638

Homepage URL


Email

toki-fkd@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 28 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

2014 Year 11 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 28 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 28 Day

Last modified on

2018 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034969


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name