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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000010712 |
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Date of registration:
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15/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ubiquinol for patients with multiple system atrophy
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Scientific title:
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Ubiquinol for patients with multiple system atrophy - Ubiquinol for patients with multiple system atrophy |
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Date of first enrolment:
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2013/05/20 |
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Target sample size:
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1 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012519 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Shoji Tsuji |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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tsuji@m.u-tokyo.ac.jp |
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Affiliation:
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The University of Tokyo, Graduate School of Medicine Department of Neurology |
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Name:
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Jun Mitsui |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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mituij-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
30years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Patients with multiple system atrophy
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Intervention(s)
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Patients with administration of ubiquinol
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Primary Outcome(s)
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2. Coenzyme q10 levels in plasma, blood mononuclear cells, and cerebrospinal fluid 1. Adverse event
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Grants from the Ministry of Health, Labor and Welfare of Japan
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Ethics review
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Status: YES
Approval date:
Contact:
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