A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)

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 75 years old, inclusive, at the time of informed consent.
3. Must weigh ≥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 ≤3 months prior to signing the informed consent
form (ICF).
6. Expected survival time of ≥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) yes
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. Unexplained epileptic seizures within 6 months prior to randomization.
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. Alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) and
aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) greater
than 5 times the upper limit of normal (>5 × ULN) at Screening, and/or bilirubin >3 × ULN
at Screening.
10. A calculated creatinine clearance <30 mL/min at Screening. 11. A marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc
interval >450 milliseconds [Msec]) at Screening or Baseline.
12. Vaccinations with live vaccines (even of attenuated viruses/bacteria) within 2 months prior
to randomization.
13. Participation in another study within 30 days prior to randomization.
14. Current treatment with quinine, quinidine, chloroquine, or halofantrine.
15. Current treatment with efavirenz, unless the subject has been on a stable dose for 30 days
prior to randomization and is expected to remain on the same dose or on a lower dose
throughout the study.
16. Female subjects who are pregnant or currently breastfeeding, or who plan to become
pregnant during the study.
17. Inability to comply with study requirements. 18. 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

Secondary Outcome Measures

Name	Time	Method

Related Trials

Phase 1

Biogen Idec Ltd

Updated 10/8/2021