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

September 3, 2008
June 7, 2012
September 2008
November 2010   (final data collection date for primary outcome measure)
Change in JCV DNA levels in CSF from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
JC viral DNA levels in cerebrospinal fluid [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00746941 on ClinicalTrials.gov Archive Site
  • 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 ]
Neurological status and brain MRI. [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy (PML)
A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy(PML)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Progressive Multifocal Leukoencephalopathy
Drug: mefloquine
250 mg orally each day for 3 days and then weekly up to 6 months.
Other Name: Lariam®
  • No Intervention: A
    Standard of Care
  • Active Comparator: B
    Standard of Care plus Mefloquine
    Intervention: Drug: mefloquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
Not Provided
November 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   France,   Germany,   Italy,   Puerto Rico,   Spain,   United Kingdom
 
NCT00746941
111JC101
Not Provided
Biogen Idec
Biogen Idec
Elan Pharmaceuticals
Not Provided
Biogen Idec
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP