UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022151 |
|---|---|
| Receipt number | R000025527 |
| Scientific Title | The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy |
| Date of disclosure of the study information | 2016/04/30 |
| Last modified on | 2019/11/05 13:57:51 |
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Basic information
Public title
The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy
Acronym
The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy
Scientific Title
The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy
Scientific Title:Acronym
The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy
Region
| Japan |
Condition
Condition
The efficacy and safety of mefloquine in patients with progressive multifocal leukoencephalopathy
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate safety and efficacy of mefloquine in progressive multifocal leukoencephalopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival time and an improvement in KPS and MMSE at baseline and 6 months thereafter.
Key secondary outcomes
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
mefloquine is to be taken orally 275mg for 3days then 275mg weekly for 6 manths
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Less than six months after PML onset.
2) JC virus positive in cerebrospinal fluid.
3) Patients who can provide consent to participate in this study by themselves or their representative.
4) 20 years old or older at the time of an agreement
Key exclusion criteria
1) Patients with other infection of the central nervous system.
2) Physical status is severe or unstable.
3) Patients with severe psychiatric disorder.
4) Pregnant women or patients with possible pregnancy.
5) Patients with a history of hypersensitivity to this drug.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chizuko Hamada |
Organization
Shimane University Hospital
Division name
Department of Neurology
Zip code
Address
89-1, Enya, Izumo, Shimane, 693-8501, japan
TEL
0853-20-2195
okuzihc.@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chizuko Hamada |
Organization
Shimane University Hospital
Division name
Department of Neurology
Zip code
Address
89-1, Enya, Izumo, Shimane, 693-8501, japan
TEL
0853-20-2195
Homepage URL
okuzihc.@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
| 2016 | Year | 04 | Month | 30 | 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
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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 24 | 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 | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025527
