NCT00746941

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

A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy (PML)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Progressive Multifocal Leukoencephalopathy

Interventions

Type	Name	Description
DRUG	mefloquine	250 mg orally each day for 3 days and then weekly up to 6 months.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-09-04
• Last updated: 2014-07-31
• Results posted: 2014-07-31

Locations

12 sites across 5 countries: United States, Brazil, Germany, Italy, Spain