Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)
Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Progressive Multifocal Leukoencephalopathy
Intervention: mefloquine (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: Biogen
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.
Clinical Details
Official title: A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy (PML)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF)
Secondary outcome: Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) ScoreChange From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT) Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS) Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains Participants Who Died Within 6 Months
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Sao Paulo, Brazil
Research Site, Berlin, Germany
Research Site, Hamburg, Germany
Research Site, Milano, Italy
Research Site, Barcelona, Spain
Research Site, Madrid, Spain
Research Site, Chicago, Illinois, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, St. Louis, Missouri, United States
Research Site, New York, New York, United States
Research Site, Dusseldorf, North Rhine-Westphalia, Germany
Additional Information
Starting date: January 2009
Last updated: July 2, 2014
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