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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009358
Receipt No. R000010995
Scientific Title Development of oral taurine therapy for the treatment of MERRF
Date of disclosure of the study information 2012/11/19
Last modified on 2018/10/09

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Basic information
Public title Development of oral taurine therapy for the treatment of MERRF
Acronym Taurine therapy for MERRF
Scientific Title Development of oral taurine therapy for the treatment of MERRF
Scientific Title:Acronym Taurine therapy for MERRF
Region
Japan

Condition
Condition MERRF
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of taurine to prevent disease progression of MERRF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Frequency of seizure
-Clinical score of cerebellar ataxia
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 Ten patients with MERRF having A8344G mutations in the mitochondrial DNA are enrolled in the study. Oral taurine (12g/d) is administered to the patients for 24 months to evaluate its effect on preventing epileptic symptoms and the progression of cerebellar ataxia.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Male and female patients over 16 years old
Key exclusion criteria none
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Ohsawa
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsusima, Kurashiki-city, Okayama 701-0192, Japan
TEL 086-462-1111
Email yosawa@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Ohsawa
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsusima, Kurashiki-city, Okayama 701-0192, Japan
TEL 086-462-1111
Homepage URL
Email yosawa@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Neurology, Kawasaki Medical School
Institute
Department

Funding Source
Organization Department of Neurology, Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Biochemistry and Cell Biology, Institute of Development and Aging Sciences, Nippon Medical School
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(岡山県)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 19 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 11 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 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
2012 Year 11 Month 19 Day
Last modified on
2018 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010995

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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