UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009358 |
|---|---|
| Receipt number | 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 15:52:59 |
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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
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
yosawa@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Neurology, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010995
