UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023752 |
|---|---|
| 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 |
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Basic information
Public title
Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance
Acronym
Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance
Scientific Title
Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance
Scientific Title:Acronym
Medication with mefloquine hydrochloride for progressive multifocal leukoencephalopathy (PML) out of the application range of insurance
Region
| Japan |
Condition
Condition
progressive multifocal leukoencephalopathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Neurological examination : evaluation by neurologists at starting, 8 weeks, 16 weeks, and 24weeks after administration (or cessation)
Key secondary outcomes
Brain MRI and quantitative JC virus DNA of cerebrospinal fluid : starting, 8 weeks, 16 weeks, and 24weeks after administration(or cessation)
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
Oral mefloquine hydrochloride 275mg once a day at first 3 days.
Since second week, 275mg in each week oral intake until 6 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients detected JC virus DNA from cerebrospinal fluid.
Patients whose clinical history, neurological examinations, and brain MRI findings are consistent with PML.
Key exclusion criteria
Patients allergic to component of this drug.
Pregnant or possibly pregnant women.
Patients chief or sub investigator diagnose inappropriate.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Okita |
Organization
Nagoya City University
Division name
Department of Neurology
Zip code
Address
Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL
052-853-8094
neuron4356@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Okita |
Organization
Nagoya City University
Division name
Department of Neurology
Zip code
Address
Aza kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya-city, Aichi
TEL
052-853-8094
Homepage URL
neuron4356@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Neurological manifestation and brain MRI findings were guradually worsened.
Mefloquine was discontinued according to family's request after 15 weeks of administration.
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
| 2016 | Year | 04 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 24 | Day |
Last modified on
| 2016 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027372
