A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)Estudio aleatorizado con evaluador en condiciones de ciego para explorar el efecto de mefloquina en sujetos con leucoencefalopatía multifocal progresiva (LMP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
2. Aged 18 to 60 years old, inclusive, at the time of informed consent.
3. Must weigh more or equal to 30 kg.
4. Must have a diagnosis of PML confirmed by detection of JCV DNA in CSF.
5. Must have onset of PML symptoms within less or equal to 3 months prior to signing the informed consent form (ICF).
6. Expected survival time of more or equal to 2 months after baseline, as determined by the Investigator.
7. All male subjects and female subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 14 weeks after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any current clinical or laboratory parameter assessed as Grade 4 in the AIDS Clinical Trial Group (ACTG) Grading System (Section 22). Asymptomatic Grade 4 laboratory abnormalities will be permitted, at the discretion of the Investigator, if the potential benefit of treatment outweighs the potential risk.
2. Concomitant opportunistic infection of the CNS.
3. Current severe illness or any other conditions that, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
4. Any condition that precludes repeated lumbar punctures.
5. Active severe mental illness (e.g., depression, anxiety, psychosis, and schizophrenia).
6. Active epilepsy.
7. Hypersensitivity to mefloquine, quinine, or quinidine, or to any component of these drugs.
8. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
9. Hepatic failure or renal failure
10. A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval >450 milliseconds [Msec]) at Screening or Baseline.
11. Vaccinations with live vaccines (even of attenuated viruses/bacteria) within 2 months prior to randomisation.
12. Participation in another study within 30 days prior to randomization.
13. Current treatment with quinine, quinidine, chloroquine, or halofantrine.
14. Female subjects who are pregnant or currently breastfeeding, or who plan to become pregnant during the study.
15. Inability to comply with study requirements.
16. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore whether mefloquine can delay or stop progression of PML as measured by JCV levels in CSF. ;Secondary Objective: 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. ;Primary end point(s): To explore whether mefloquine can delay or stop progression of PML as measured by JCV DNA levels in CSF.

Secondary Outcome Measures

Name	Time	Method

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