Study to Explore the Effect of Mefloquine in Subjects With Progressive Multifocal Leukoencephalopathy (PML)
This study has been terminated.
Sponsor:
Biogen Idec
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130312000430im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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:
MedlinePlus related topics:
Neurologic Diseases
Drug Information available for:
Mefloquine hydrochloride
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®
|
![](https://webarchive.library.unt.edu/web/20130312000430im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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.
![](https://webarchive.library.unt.edu/web/20130312000430im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746941
Show 28 Study Locations
![](https://webarchive.library.unt.edu/web/20130312000430im_/http://clinicaltrials.gov/ct2/html/images/frame/plus.gif)
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
![](https://webarchive.library.unt.edu/web/20130312000430im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 March 10, 2013