一项1b期、多中心、开放标签研究，旨在评估大麻二酚口服溶液（CBD-OS [GWP42003-P, JZP926]）治疗局灶性发作癫痫的有效性和安全性
一项1b期、多中心、开放标签、单臂研究，旨在评估大麻二酚口服溶液（CBD-OS [GWP42003-P, JZP926]）在12至75岁局灶性癫痫发作患者中的疗效和安全性
Cannabidiol oral solution (CBD-OS) is approved in the US for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or Tuberous sclerosis complex (TSC) in patients 1 year of age and older. This study will assess the efficacy and safety of CBD-OS in participants aged 12 to 75 years for the treatment of focal-onset seizures (FOS).
研究概览
详细说明
This study will assess the efficacy of CBD-OS as an adjunctive treatment in reducing the frequency of focal seizures compared to baseline as well as the effect of CBD-OS on health outcome endpoints in early line and refractory participants with FOS. This study will also examine pharmacokinetics (PK), safety, and potential predictors or mediators of treatment response, including functional magnetic resonance imaging (fMRI) and neuropsychological testing in a substudy.
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Clinical Trial Disclosure & Transparency
- 电话号码：215-832-3750
- 邮箱：ClinicalTrialDisclosure@JazzPharma.com
学习地点
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Arizona
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Phoenix、Arizona、美国、85006
- 招聘中
- Banner University Medical Center-Phoenix
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California
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La Jolla、California、美国、92037-1300
- 招聘中
- UC San Diego
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Connecticut
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New Haven、Connecticut、美国、06510
- 招聘中
- Yale University
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Florida
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Miami、Florida、美国、33176
- 尚未招聘
- Serenity Research Center, LLC
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Tampa、Florida、美国、33606
- 招聘中
- University of South Florida
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Georgia
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Atlanta、Georgia、美国、30329
- 招聘中
- Emory University
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Savannah、Georgia、美国、31406
- 招聘中
- Savannah Neurology Specialists
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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Northwestern University
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Maryland
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Bethesda、Maryland、美国、20817
- 招聘中
- Mid-Atlantic Epilepsy and Sleep Center
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Michigan
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Detroit、Michigan、美国、48201
- 招聘中
- Wayne State University
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Grand Rapids、Michigan、美国、49503
- 尚未招聘
- Corewell Health
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New Jersey
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Edison、New Jersey、美国、08820
- 招聘中
- Hackensack Meridian Neuroscience Institute at JFK University Medical Center
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New Brunswick、New Jersey、美国、08901
- 招聘中
- Saint Peter's University Hospital
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New York
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Hawthorne、New York、美国、10532
- 招聘中
- Boston Children's Health Physicians
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North Carolina
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Raleigh、North Carolina、美国、27607
- 招聘中
- Velocity Clinical Research at Raleigh Neurology
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Ohio
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Cincinnati、Ohio、美国、45229
- 招聘中
- Cincinnati Children's Hospital
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Cincinnati、Ohio、美国、45267-0525
- 招聘中
- University of Cincinnati, Gardner Neuroscience Institute
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Oregon
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Portland、Oregon、美国、97239
- 招聘中
- Oregon Health & Science University
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- 尚未招聘
- Thomas Jefferson University
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Tennessee
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Memphis、Tennessee、美国、38103
- 招聘中
- Le Bonheur Children's Hospital
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Texas
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Austin、Texas、美国、78757
- 招聘中
- Child Neurology & Consultants of Austin
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El Paso、Texas、美国、79912
- 招聘中
- ANESC Research
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Utah
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Murray、Utah、美国、84107
- 招聘中
- Intermountain Health
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Washington
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Seattle、Washington、美国、98105
- 招聘中
- Seattle Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Participants are eligible to be included in the main study only if all of the following criteria apply:
- Participant has a documented diagnosis of focal epilepsy according to the ILAE Classification of Epilepsy, 2017, characterized by focal seizure types with typical interictal/ictal EEG findings (eg, history of an EEG with focal sharp waves or slowing). Participants with a documented diagnosis of focal epilepsy and a normal EEG are eligible for inclusion.
- Participant is currently treated with at least 1, but no more than 4, antiseizure medications on a stable regimen.
- Participant is aged 12 to 75 years old, inclusive, at Screening.
Participants are excluded from the study if any of the following criteria apply:
- Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.
- Has clinically significant unstable medical condition(s), other than epilepsy.
- History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.
- Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention, such as sesame oil.
- Is currently treated with Epidiolex or received treatment with Epidiolex within 28 days prior to Screening (Visit 1).
- Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to Screening (Visit 1) and/or is unwilling to abstain for the duration of the study.
- Presence of only nonmotor focal aware seizures or primary generalized epilepsies.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CBD-OS
Participants who will receive open-label CBD-OS. |
Starting dose of CBD-OS will be administered as per the approved local product label
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
与基线相比可计数局灶性癫痫发作频率的百分比变化
大体时间：基线期至第16周
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基线期至第16周
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.