Unique ID issued by UMIN | UMIN000023752 |
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Receipt number | R000027372 |
Scientific Title | Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance |
Date of disclosure of the study information | 2016/08/24 |
Last modified on | 2016/08/24 22:17:36 |
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
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
Japan |
progressive multifocal leukoencephalopathy
Neurology |
Others
NO
PML indicates a very poor prognosis, and leukoencephalopathy of the central nervous system caused by reactivation of JC virus in an cell-mediated immunosuppressed host.
There is no approved therapy in non-HIV-associated PML, mefloquine, drug for malaria, is reported to suppress JC virus proliferation in vitro, and to be effective in some clinical cases.
Immediate administration of mefloquine with high safety is promising to suppress or reduce the disease progression, even out of the application range of insurance.
Efficacy
Exploratory
Pragmatic
Not applicable
Neurological examination : evaluation by neurologists at starting, 8 weeks, 16 weeks, and 24weeks after administration (or cessation)
Brain MRI and quantitative JC virus DNA of cerebrospinal fluid : starting, 8 weeks, 16 weeks, and 24weeks after administration(or cessation)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Oral mefloquine hydrochloride 275mg once a day at first 3 days.
Since second week, 275mg in each week oral intake until 6 months
Not applicable |
Not applicable |
Male and Female
Patients detected JC virus DNA from cerebrospinal fluid.
Patients whose clinical history, neurological examinations, and brain MRI findings are consistent with PML.
Patients allergic to component of this drug.
Pregnant or possibly pregnant women.
Patients chief or sub investigator diagnose inappropriate.
1
1st name | |
Middle name | |
Last name | Kenji Okita |
Nagoya City University
Department of Neurology
Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
052-853-8094
neuron4356@yahoo.co.jp
1st name | |
Middle name | |
Last name | Kenji Okita |
Nagoya City University
Department of Neurology
Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
052-853-8094
neuron4356@yahoo.co.jp
Nagoya City University
Nagoya City University
Self funding
NO
2016 | Year | 08 | Month | 24 | Day |
Unpublished
Neurological manifestation and brain MRI findings were guradually worsened.
Mefloquine was discontinued according to family's request after 15 weeks of administration.
Completed
2016 | Year | 04 | Month | 13 | Day |
2016 | Year | 04 | Month | 14 | Day |
2016 | Year | 08 | Month | 01 | Day |
2016 | Year | 08 | Month | 24 | Day |
2016 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027372
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