UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019195
Receipt number R000022183
Scientific Title A multicentre, long-term trial of KN01 in patients with MELAS
Date of disclosure of the study information 2015/10/08
Last modified on 2019/02/25 11:11:22

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Basic information

Public title

A multicentre, long-term trial of KN01 in patients with MELAS

Acronym

Long-term taurine-MELAS study

Scientific Title

A multicentre, long-term trial of KN01 in patients with MELAS

Scientific Title:Acronym

Long-term taurine-MELAS study

Region

Japan


Condition

Condition

MELAS

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To confirm the long-term efficacy and safety of taurine supplementation therapy for prevention of stroke-like episodes in patients with MELAS

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

(1)efficiency:annual relapsing rates of stroke-like episodes.
(2)safety:adverse events and advise effects

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

taurine supplementation:
(1)duration:104 wks
(2)dose: 12 g (BW>40 kg), 9 g (BW:25-40 kg), 6 g (BW:15-25 kg), 3 g (BW<15 kg)
(3)times: TID
(4)frequency: daily

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

Patients agreed with the long-term taurine supplementation study, who priorly participated in the short -term one (UMIN000011908) .

Key exclusion criteria

Same as the prior short-term study.

Target sample size

9


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, Kurashiki, Okayama

TEL

086-462-1111

Email

ysunada@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mai Moriyama

Organization

CTD inc.

Division name

Medical Prodiucts Promotion Division

Zip code


Address

3-3-2, Tsukiji, Chuo-ku, Tokyo,

TEL

03-6228-4105

Homepage URL

https://www.c-ctd.co.jp/project_sn01/researcher/contents/documents.html

Email

taurine@c-ctd.co.jp


Sponsor or person

Institute

Kawasaki Medical School Hospital

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2015 Year 10 Month 08 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

2015 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 01 Day

Last modified on

2019 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name