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

This study has been terminated.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00746941
First received: September 3, 2008
Last updated: June 7, 2012
Last verified: December 2011
History of Changes
  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
Progressive Multifocal Leukoencephalopathy
 Drug: mefloquine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Change in JCV DNA levels in CSF from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Karnofsky Performance Scale Index (KPSI) from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in Expanded Disability Status Scale (EDSS) from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in Symbol Digit Modalities Test (SDMT) from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in Visual Analogue Scale (VAS) from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Number of gadolinium-enhancing lesions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in volume of T1 hypointense lesions from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in volume of T2 hyperintense lesions from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Assessment of mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2008
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Standard of Care
Active Comparator: B
Standard of Care plus Mefloquine
 Drug: mefloquine
250 mg orally each day for 3 days and then weekly up to 6 months.
Other Name: Lariam®

  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:

  • 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.

Other protocol-defined criteria may also apply.

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

  Show 28 Study Locations
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00746941     History of Changes
Other Study ID Numbers: 111JC101
Study First Received: September 3, 2008
Last Updated: June 7, 2012
Health Authority: Brazil: National Health Surveillance Agency
United States: Institutional Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Biogen Idec:
PML
Human Polyomavirus JC
HIV
 Central Nervous System Disease
Mefloquine
JC Virus

Additional relevant MeSH terms:
Leukoencephalopathy, Progressive Multifocal
Leukoencephalopathies
Encephalitis, Viral
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Central Nervous System Infections
Demyelinating Diseases
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013