EUCTR2008-001314-24-IT进行中（未招募）不适用
A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML) - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)Progressive Multifocal Leukoencephalopathy (PML)MedDRA version: 9.1Level: LLTClassification code 10036807Term: Progressive multifocal leukoencephalopathyEUCTR2008-001314-24-FRBiogen Idec Ltd40
进行中（未招募）
1 期
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)Progressive Multifocal Leukoencephalopathy (PML)Leucoencefalopatía Multifocal Progresiva (LMP)MedDRA version: 9.1Level: LLTClassification code 10036807Term: Progressive multifocal leukoencephalopathyEUCTR2008-001314-24-ESBiogen Idec Ltd40
进行中（未招募）
不适用
A Randomized, Rater-Blinded Study to Explore the Effect of Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)EUCTR2008-001314-24-GBBiogen Idec Ltd60
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Tideglusib Versus Placebo for the Treatment of Children and Adolescents with Congenital Myotonic DystrophyTreatment of child and adolescent congenital myotonic dystrophy.MedDRA version: 20.0 Level: PT Classification code 10068871 Term: Myotonic dystrophy System Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2016-004623-23-GBAMO Pharma Ltd56
进行中（未招募）
1 期
Study of two different doses of cabozantinib in progressive, metastatic medullary thyroid cancerProgressive Metastatic Medullary Thyroid CancerMedDRA version: 21.1 Level: PT Classification code 10027105 Term: Medullary thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003402-40-HUExelixis, Inc.250