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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00746941
• Date of registration: 03/09/2008
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)
• Scientific title: A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy (PML)
• Date of first enrolment: January 2009
• Target sample size: 37
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00746941
• Study type: Interventional
• Phase: Phase 1/Phase 2

Countries of recruitment

Australia, Brazil, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Diagnosis of PML confirmed by detection of JCV DNA in CSF.

- Onset of PML symptoms within 6 months prior to study.

Key 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.

Note: Other protocol-defined criteria may also apply.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Multifocal Leukoencephalopathy

Intervention(s)

Drug: mefloquine

Primary Outcome(s)

Change From Baseline to Week 4 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF) [Time Frame: Day 0 (baseline), Week 4]

Change From Baseline to Week 8 in JC Virus (JCV) Load in Cerebrospinal Fluid (CSF) [Time Frame: Day 0 (baseline), Week 8]

Secondary Outcome(s)

Change From Baseline to Week 4 and Week 8 in T1 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains [Time Frame: Day 0 (baseline), Week 4, Week 8]

Change From Baseline to Week 4 and Week 8 in Karnofsky Performance Status (KPS) Index Score [Time Frame: Day 0 (baseline), Week 4, Week 8]

Change From Baseline to Week 4 and Week 8 in Symbol Digit Modalities Test (SDMT) [Time Frame: Day 0 (baseline), Week 4, Week 8]

Participants Who Died Within 6 Months [Time Frame: Day 1 up to 6 months]

Change From Baseline to Week 4 and Week 8 in T2 Lesion Volume as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains [Time Frame: Day 0 (baseline), Week 4, Week 8]

Participants With Gadolinium (Gd)-Enhanced Lesions at Baseline, Week 4 and Week 8 as Seen on Magnetic Resonance Imaging (MRI) Scans of Participants' Brains [Time Frame: Day 0 (baseline), Week 4, Week 8]

Change From Baseline to Week 4 and Week 8 in Participants' Neurological Function Using a Visual Analog Scale (VAS) [Time Frame: Day 0 (baseline), Week 4, Week 8]

Change From Baseline to Week 4 and Week 8 in the Expanded Disability Status Scale (EDSS) Score [Time Frame: Day 0 (baseline), Week 4 and 8]

Secondary ID(s)

111JC101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Elan Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 31/07/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00746941