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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 August 2022 |
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Main ID: |
EUCTR2008-001314-24-ES |
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Date of registration:
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11/07/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 leucoencefalopatÃa multifocal progresiva (LMP)
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Scientific title:
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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 leucoencefalopatÃa multifocal progresiva (LMP) |
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Date of first enrolment:
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19/11/2008 |
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Target sample size:
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40 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001314-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Randomised, rater-blinded
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Local standard of care
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Italy
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Progressive Multifocal Leukoencephalopathy (PML)
LeucoencefalopatÃa Multifocal Progresiva (LMP)
MedDRA version: 9.1
Level: LLT
Classification code 10036807
Term: Progressive multifocal leukoencephalopathy
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Intervention(s)
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Trade Name: Lariam
Product Name: Mefloquine
Product Code: 111JC101
Pharmaceutical Form: Tablet
INN or Proposed INN: MEFLOQUINE
CAS Number: 53230107
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
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Primary Outcome(s)
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Main Objective: To explore whether mefloquine can delay or stop progression of PML as measured by JCV levels in CSF.
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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.
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Primary end point(s): To explore whether mefloquine can delay or stop progression of PML as measured by JCV DNA levels in CSF.
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Secondary ID(s)
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2008-001314-24-GB
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111JC101
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 16/09/2008
Contact:
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