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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) Score

Change 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

Page last updated: August 23, 2015

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