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

This study is currently recruiting participants.

Verified by Biogen Idec, August 2009

First Received: September 3, 2008 Last Updated: August 31, 2009 History of Changes

Sponsor:	Biogen Idec
Collaborator:	Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00746941

Purpose

The purpose of the study is to explore if mefloquine works to slow or stop the worsening of PML and to better understand PML. We will measure if mefloquine is working by determining if it reduces the level of JC virus in spinal fluid, as well as, clinical and MRI measures.

Condition	Intervention	Phase
Leukoencephalopathy, Progressive Multifocal HIV Infections	Drug: mefloquine	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy(PML)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Mefloquine hydrochloride Mefloquine

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

JC viral DNA levels in cerebrospinal fluid [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurological status and brain MRI. [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Standard of Care
B: Active Comparator Standard of Care plus Mefloquine	Drug: mefloquine 250 mg orally each day for 3 days and then weekly up to 6 months.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of PML confirmed by detection of JC viral DNA in spinal fluid.
Onset of PML symptoms within 6 months prior to study.

Exclusion Criteria:

Concomitant 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.

Other protocol-defined criteria may also apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746941

Contacts

Contact: Biogen Idec

neurologyclinicaltrials@biogenidec.com

Show 28 Study Locations

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators

Study Director:

Medical Director

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec ( Biogen Idec )
Study ID Numbers:	111JC101
Study First Received:	September 3, 2008
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00746941 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: National Health Surveillance Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; United States: Institutional Review Board; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:

PML
HIV
JC Virus

Central Nervous System Disease
Human Polyomavirus JC
Mefloquine

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Antiprotozoal Agents
Slow Virus Diseases
Polyomavirus Infections
Central Nervous System Viral Diseases
Infection
Encephalitis, Viral
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Mefloquine
Retroviridae Infections
RNA Virus Infections
Immune System Diseases

Demyelinating Diseases
Acquired Immunodeficiency Syndrome
Nervous System Diseases
Leukoencephalopathy, Progressive Multifocal
Central Nervous System Diseases
Pharmacologic Actions
Immunologic Deficiency Syndromes
Encephalitis
Virus Diseases
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on February 08, 2010