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

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Collaborator: Elan Pharmaceuticals
• Treatments: Mefloquine

Criteria

Key Inclusion Criteria:

• Diagnosis of PML confirmed by detection of JCV DNA in CSF.

• Onset of PML symptoms within 6 months prior to study.

Key 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.