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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-UMIN000023752 |
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Date of registration:
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24/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance
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Scientific title:
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Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance - Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance |
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Date of first enrolment:
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2016/04/14 |
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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=R000027372 |
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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 applicable
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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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Kenji Okita |
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Address:
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Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
Japan |
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Telephone:
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052-853-8094 |
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Email:
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neuron4356@yahoo.co.jp |
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Affiliation:
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Nagoya City University Department of Neurology |
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Name:
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Kenji Okita |
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Address:
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Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
Japan |
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Telephone:
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052-853-8094 |
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Email:
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neuron4356@yahoo.co.jp |
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Affiliation:
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Nagoya City University Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients allergic to component of this drug. Pregnant or possibly pregnant women. Patients chief or sub investigator diagnose inappropriate.
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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progressive multifocal leukoencephalopathy
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Intervention(s)
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Oral mefloquine hydrochloride 275mg once a day at first 3 days. Since second week, 275mg in each week oral intake until 6 months
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Primary Outcome(s)
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Neurological examination : evaluation by neurologists at starting, 8 weeks, 16 weeks, and 24weeks after administration (or cessation)
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Secondary Outcome(s)
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Brain MRI and quantitative JC virus DNA of cerebrospinal fluid : starting, 8 weeks, 16 weeks, and 24weeks after administration(or cessation)
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Source(s) of Monetary Support
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Nagoya City University
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/08/2016 |
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URL:
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