UMIN-CTR Clinical Trial

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
Email	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
Email	okuzihc.@med.shimane-u.ac.jp

Sponsor
Institute	Department of Neurology, Shimane University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025527