Status:
TERMINATED
Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Progressive Multifocal Leukoencephalopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 JC...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of PML confirmed by detection of JCV DNA in CSF.
- Onset of PML symptoms within 6 months prior to study.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00746941
Start Date
January 1 2009
End Date
November 1 2010
Last Update
July 31 2014
Active Locations (12)
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1
Research Site
Chicago, Illinois, United States
2
Research Site
Baltimore, Maryland, United States
3
Research Site
Boston, Massachusetts, United States
4
Research Site
St Louis, Missouri, United States