UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029376
Receipt number R000033379
Scientific Title Safety follow-up survey for MELAS taurine high-dose therapy subjects after completion of doctor-initiated clinical trial
Date of disclosure of the study information 2017/10/16
Last modified on 2019/03/27 09:03:57

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Basic information

Public title

Safety follow-up survey for MELAS taurine high-dose therapy subjects after completion of doctor-initiated clinical trial

Acronym

Safety follow-up survey for MELAS taurine high-dose therapy subjects

Scientific Title

Safety follow-up survey for MELAS taurine high-dose therapy subjects after completion of doctor-initiated clinical trial

Scientific Title:Acronym

Safety follow-up survey for MELAS taurine high-dose therapy subjects

Region

Japan


Condition

Condition

MELAS

Classification by specialty

Medicine in general Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We started doctor-initiated clinical trial of Taurine high-dose therapy (9-12 g / day) by registering 10 MELAS patients in 10 medical institutions nationwide from October 2013, In terminating the doctor-initiated clinical trial in October - December 2017, this study aims to further pursue long-term safety of Taurine high-dose therapy for subjects to be examined (up to 8 cases).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety assessment: (i) adverse event report, (ii) annual blood test

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

Treatment

Type of intervention

Medicine

Interventions/Control_1

High-dose taurine supplementation; 9-12 g/day,, three times after meal, every day.

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

Subjects continuing the taurine bulk mass method in doctor-initiated clinical trials beginning in 2013, up to 8 subjects

Key exclusion criteria

None

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihide Sunada

Organization

Kawasaki medical School

Division name

Neurology

Zip code


Address

577 Matsushima, Okayama 701-0192, Japan

TEL

086-462-1111

Email

ysunada@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihide Sunada

Organization

Kawasaki medical School

Division name

Neurology

Zip code


Address

577 Matsushima, Okayama 701-0192, Japan

TEL

086-462-1111

Homepage URL


Email

ysunada@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Non profit foundation

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

川崎医科大学附属病院
社会福祉法人聖隷福祉事業団 総合病院 聖隷浜松病院


Other administrative information

Date of disclosure of the study information

2017 Year 10 Month 16 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

2017 Year 09 Month 20 Day

Date of IRB

2017 Year 10 Month 16 Day

Anticipated trial start date

2017 Year 10 Month 16 Day

Last follow-up date

2019 Year 03 Month 13 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 10 Month 02 Day

Last modified on

2019 Year 03 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033379


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name