Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

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The primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF). The secondary objective of the study was to explore whether mefloquine can delay or stop progression of PML based on neurological deterioration, magnetic resonance imaging (MRI) measures of brain lesion evolution or the formation of new lesions, and mortality.

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Detailed Description

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Conditions

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Progressive Multifocal Leukoencephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Local standard of care

All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants in this treatment arm had the option of adding 250 mg mefloquine by mouth at Week 4 (Day 28) or Week 8 (Day 56) daily for 3 days, and then weekly through Week 24.

Group Type NO_INTERVENTION

No interventions assigned to this group

Local standard of care plus mefloquine 250 mg

All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants received 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.

Group Type EXPERIMENTAL

mefloquine

Intervention Type DRUG

250 mg orally each day for 3 days and then weekly up to 6 months.

Interventions

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mefloquine

250 mg orally each day for 3 days and then weekly up to 6 months.

Intervention Type DRUG

Other Intervention Names

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Lariam® Mephaquin® Mefliam®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of PML confirmed by detection of JCV DNA in CSF.
* Onset of PML symptoms within 6 months prior to study.

Exclusion Criteria

* Other opportunistic infection of the central nervous system.
* Current severe illness or any other conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
* Active severe mental illness (e.g., depression, anxiety, psychosis, and schizophrenia).
* Hypersensitivity to mefloquine, quinine, or quinidine, or to any component of these drugs.
* Current treatment with quinine, quinidine, chloroquine, or halofantrine.

Note: Other protocol-defined criteria may also apply.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No