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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010712
Receipt No. R000012519
Scientific Title Ubiquinol for patients with multiple system atrophy
Date of disclosure of the study information 2013/05/15
Last modified on 2017/11/17

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Basic information
Public title Ubiquinol for patients with multiple system atrophy
Acronym Ubiquinol for patients with multiple system atrophy
Scientific Title Ubiquinol for patients with multiple system atrophy
Scientific Title:Acronym Ubiquinol for patients with multiple system atrophy
Region
Japan

Condition
Condition Patients with multiple system atrophy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To estimate the safety and the effect of ubiquinol for patients with multiple system atrophy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2. Coenzyme q10 levels in plasma, blood mononuclear cells, and cerebrospinal fluid
1. Adverse event
Key secondary outcomes 1. UMSARS Part II
2. Urinary 8-OHdG
3. Glucose metabolism of the cerebellum on FEG-PET
4. Oxygen metabolism of the cerebellum on 15O-PET

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 Patients with administration of ubiquinol
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects diagnosed as probable or possible multiple system atrophy on the basis of the Gilman criteria
2. Subjects in a genetic test with homozygous or compound heterozygous mutations in the COQ2 gene
3. Male or female subjects between the ages of 30 and 80 at time of informed consent
4. Subjects who can get an informed consent from themselves
5. Subjects who can be admitted to the university of Tokyo hospital
Key exclusion criteria 1. Subjects having received ubiquinone, ubiquinol, or idebenone
2. Subjects with severe liver dysfunction (Child-Pugh class A-C)
3. Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period
4. Subjects who have received any investigational drug within 12 weeks prior to informed consent
5. Subjects who are determined as unfit for the study by attending physicians for reasons other than those stated above
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Tsuji
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL 03-3815-5411
Email tsuji@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Mitsui
Organization The University of Tokyo Hospital
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
TEL 03-3815-5411
Homepage URL
Email mituij-tky@umin.ac.jp

Sponsor
Institute Department of Neurology, the University of Tokyo Hospital
Institute
Department

Funding Source
Organization Grants from the Ministry of Health, Labor and Welfare of Japan
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
2013 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28150130
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
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
2017 Year 07 Month 18 Day
Date of closure to data entry
2017 Year 07 Month 18 Day
Date trial data considered complete
2017 Year 07 Month 18 Day
Date analysis concluded
2017 Year 07 Month 18 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 14 Day
Last modified on
2017 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012519

Research Plan
Registered date File name
2017/11/17 12311_2017_Article_846.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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