UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010712 |
|---|---|
| Receipt number | 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 16:16:12 |
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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
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
mituij-tky@umin.ac.jp
Sponsor or person
Institute
Department of Neurology, the University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012519
