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临床试验/EUCTR2022-001991-32-FR
EUCTR2022-001991-32-FR进行中（未招募）1 期

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, BIOMARKERS, AND EFFICACY OF TOMINERSEN IN INDIVIDUALS WITH PRODROMAL AND EARLY MANIFEST HUNTINGTON’S DISEASE

F.Hoffmann-La Roche Ltd0 个研究点目标入组 300 人开始时间: 2024年5月27日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
300
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •- Age 25-50 years
  • •- Huntington's disease (HD) gene expansion mutation carrier status
  • •- Prodromal HD or Early manifest HD
  • •- Estimated glomerular filtration rate >= 60 mL/min/1.73 m2 in at least
  • •one out of two maximum screening samples
  • •- Total body weight > 40 kg and a body mass index within the range of
  • •18-32 kg/m2
  • •- Ability to read the words red, blue, and green and be fluent in the
  • •language of the Informed Consent and the tests used at the study site
  • •- Ability to walk unassisted without a cane or walker and move about
  • •without a wheelchair on a daily basis as determined at screening and
  • •baseline visit (Day 1)
  • •- Ability to undergo and tolerate MRI scans
  • •- Ability to tolerate blood draws and lumbar punctures (LPs)
  • •- Stable medical, psychiatric, and neurologic status as assessed by
  • •physician for at least 12 weeks prior to screening and at the time of
  • •- Negative hepatitis B surface antigen test at screening
  • •- Negative hepatitis C virus (HCV) antibody test at screening, or a
  • •positive HCV antibody test followed by a negative HCV ribonucleic acid
  • •(RNA) test at screening
  • •- For female participants of childbearing potential: agreement to remain
  • •abstinent (refrain from heterosexual intercourse) or use contraception
  • •and agree to refrain from donating eggs during the treatment period and
  • •for 5 months after the final dose of the study drug. Female participants
  • •must refrain from donating eggs during this same period
  • •- For male participants: agreement to remain abstinent (refrain from
  • •heterosexual intercourse) or use a condom and agree to refrain from
  • •donating sperm during the treatment period and for 5 months after the
  • •final dose of the study drug to avoid exposing the embryo. Male
  • •participants must refrain from donating sperm during this same period
  • •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 300
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •- History of attempted suicide or suicidal ideation with plan that required
  • •hospital visit and/or change in level of care within 12 months prior to
  • •- Active psychosis, confusional state, or violent behavior, including
  • •aggression that could cause harm to self or others, over the 12 weeks
  • •prior to screening
  • •- Clinical diagnosis of chronic migraines as per the International
  • •Headache Society Classification of Headache Disorders
  • •- Pregnancy or breastfeeding, or intention of becoming pregnant during
  • •the study or within 5 months after the final dose of study drug
  • •- Presence of an implanted shunt for the drainage of CSF or an implanted
  • •central nervous system (CNS) catheter
  • •- Hydrocephalus
  • •- History of deep brain stimulation
  • •- Known human immunodeficiency viruses (HIV) infection
  • •- An infection requiring oral or intravenous antibiotics within 14 days
  • •prior to screening, during screening and prior to randomization
  • •- Anti-retroviral medications, including anti-retroviral medication taken
  • •as prophylaxis within 12 months of study enrollment
  • •- Current or previous use of an antisense oligonucleotide (ASO) or any
  • •huntingtin protein (HTT) lowering therapy
  • •- Treatment with investigational therapy within 4 weeks or 5 drugelimination
  • •half-lives, whichever is longer, prior to screening
  • •- Current or previous history of a primary independent psychotic
  • •- Current use of anti-psychotics for motor symptoms or mood
  • •stabilization and/or tetrabenazine, valbenazine, or deutetrabenazine at
  • •a dose that has not been stable for at least 12 weeks prior to screening
  • •or is anticipated to change during the study, including at screening
  • •- Cholinesterase inhibitors, memantine, or riluzole use within 12 weeks
  • •from initiation of study treatment
  • •- Current use of amantadine, anti-depressant or benzodiazepine at a
  • •dose that has not been stable for at least 12 weeks prior to screening or
  • •is anticipated to change during the study, including at screening
  • •- Current use of supplements used to treat HD symptoms, including in an
  • •experimental setting, at a dose that has not been stable for at least 6
  • •weeks prior to screening or is anticipated to change during the study,
  • •including at screening
  • •- Anti-platelet or anticoagulant therapy within 14 days prior to screening
  • •- History of bleeding diathesis or coagulopathy
  • •- Platelet count less than the lower limit of normal
  • •- History of gene therapy, cell transplantation, or brain surgery
  • •- Planned brain surgery during the study
  • •- Concurrent or planned participation in any interventional clinical study,
  • •including explicit pharmacological and non-pharmacological
  • •interventions. Observational studies are acceptable; however, data
  • •collection is not permitted between screening and baseline visits and
  • •throughout the duration of the study
  • •- Poor peripheral venous access
  • •- Scoliosis or spinal deformity or surgery making intrathecal (IT)
  • •injection not feasible in an outpatient setting and potentially interfering
  • •with distribution of tominersen up the neuraxis
  • 另有 5 项未显示

研究者

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