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一项测试 Staccato 阿普唑仑在 12 岁及以上有刻板性长期癫痫发作的研究参与者中的安全性和耐受性的研究

2026年9月24日 更新者：UCB Biopharma SRL

一项开放标签、多中心、门诊扩展研究，以评估 Staccato 阿普唑仑在 12 岁及以上有刻板性长期癫痫发作的研究参与者中的安全性和耐受性

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

300

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国
        • Ep0165 20246
      • Beijing、中国
        • Ep0165 20268
      • Beijing、中国
        • Ep0165 20299
      • Changchun、中国
        • Ep0165 20261
      • Chengdu、中国
        • Ep0165 20133
      • Chengdu、中国
        • Ep0165 20137
      • Chongqing、中国
        • Ep0165 20334
      • Fuzhou、中国
        • Ep0165 20179
      • Guangzhou、中国
        • Ep0165 20264
      • Guangzhou、中国
        • Ep0165 20269
      • Guangzhou、中国
        • Ep0165 20124
      • Guangzhou、中国
        • Ep0165 20300
      • Hangzhou、中国
        • Ep0165 20022
      • Kunming、中国
        • Ep0165 20320
      • Lanzhou、中国
        • Ep0165 20258
      • Nanjing、中国
        • Ep0165 20267
      • Nanning、中国
        • Ep0165 20331
      • Qingdao、中国
        • Ep0165 20333
      • Shanghai、中国
        • Ep0165 20292
      • Shijiazhuang、中国
        • Ep0165 20289
      • Suzhou、中国
        • Ep0165 20119
      • Tianjin、中国
        • Ep0165 20257
      • Wenzhou、中国
        • Ep0165 20025
      • Zhanjiang、中国
        • Ep0165 20262
      • Zhengzhou、中国
        • Ep0165 20251
  • 保加利亚
      • Blagoevgrad、保加利亚
        • Ep0165 40650
      • Pazardzhik、保加利亚
        • Ep0165 40708
      • Pleven、保加利亚
        • Ep0165 40665
      • Sofia、保加利亚
        • Ep0165 40651
  • 匈牙利
      • Balassagyarmat、匈牙利
        • Ep0165 40666
      • Budapest、匈牙利
        • Ep0165 40673
      • Budapest、匈牙利
        • Ep0165 40704
      • Debrecen、匈牙利
        • Ep0165 40653
  • 德国
      • Berlin、德国
        • Ep0165 40683
      • Bielefeld、德国
        • Ep0165 40685
      • Erlangen、德国
        • Ep0165 40023
      • Frankfurt am Main、德国
        • Ep0165 40645
      • Marburg、德国
        • Ep0165 40529
  • 意大利
      • Genova、意大利
        • Ep0165 40674
      • Milan、意大利
        • Ep0165 40144
      • Pavia、意大利
        • Ep0165 40477
      • Roma、意大利
        • Ep0165 40257
      • Roma、意大利
        • Ep0165 40675
  • 捷克语
      • Brno、捷克语
        • Ep0165 40670
      • Ostrava - Poruba、捷克语
        • Ep0165 40672
      • Prague、捷克语
        • Ep0165 40063
      • Prague、捷克语
        • Ep0165 40671
      • Prague、捷克语
        • Ep0165 40714
  • 日本
      • Fukuoka、日本
        • Ep0165 20248
      • Hachioji-shi、日本
        • Ep0165 20070
      • Hiroshima、日本
        • Ep0165 20249
      • Hōfu、日本
        • Ep0165 20236
      • Itami、日本
        • Ep0165 20239
      • Kodaira、日本
        • Ep0165 20143
      • Koshi-shi、日本
        • Ep0165 20315
      • Kyoto、日本
        • Ep0165 20147
      • Niigata、日本
        • Ep0165 20238
      • Osaka、日本
        • Ep0165 20302
      • Sapporo、日本
        • Ep0165 20316
      • Shimotsuga-gun、日本
        • Ep0165 20337
      • Shinjuku-ku、日本
        • Ep0165 20297
      • Shizuoka、日本
        • Ep0165 20240
      • Suita、日本
        • Ep0165 20242
      • Tōon、日本
        • Ep0165 20266
      • Yamagata、日本
        • Ep0165 20244
      • Ōmura、日本
        • Ep0165 20241
  • 波兰
      • Bydgoszcz、波兰
        • Ep0165 40707
      • Gdansk、波兰
        • Ep0165 40677
      • Krakow、波兰
        • Ep0165 40842
      • Lublin、波兰
        • Ep0165 40676
      • Nowa Sól、波兰
        • Ep0165 40091
      • Świdnik、波兰
        • Ep0165 40678
  • 澳大利亚
      • Fitzroy、澳大利亚
        • Ep0165 30016
      • Herston、澳大利亚
        • Ep0165 30030
      • South Brisbane、澳大利亚
        • Ep0165 30031
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85004
        • Ep0165 50506
      • Scottsdale、Arizona、美国、85253
        • Ep0165 50720
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Ep0165 50494
    • California
      • Downey、California、美国、90242
        • Ep0165 50118
      • La Jolla、California、美国、92037
        • Ep0165 50416
      • Long Beach、California、美国、90806
        • Ep0165 50702
      • Poway、California、美国、92064
        • Ep0165 50722
      • Sacramento、California、美国、95817
        • Ep0165 50716
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20037
        • Ep0165 50088
    • Florida
      • Gulf Breeze、Florida、美国、32561
        • Ep0165 50515
      • Jacksonville、Florida、美国、32224
        • Ep0165 50342
      • Jacksonville、Florida、美国、32209-6533
        • Ep0165 50508
      • Miami、Florida、美国、33136
        • Ep0165 50199
      • Miami、Florida、美国、33176
        • Ep0165 50676
      • Orlando、Florida、美国、32806
        • Ep0165 50509
      • Rockledge、Florida、美国、32955
        • Ep0165 50703
      • Tampa、Florida、美国、33606
        • Ep0165 50308
    • Hawaii
      • Honolulu、Hawaii、美国、96817
        • Ep0165 50323
    • Idaho
      • Boise、Idaho、美国、83702
        • Ep0165 50512
    • Illinois
      • Chicago、Illinois、美国、60611
        • Ep0165 50493
    • Indiana
      • Fort Wayne、Indiana、美国、46845
        • Ep0165 50504
    • Louisiana
      • New Orleans、Louisiana、美国、70122
        • Ep0165 50517
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Ep0165 50047
      • Boston、Massachusetts、美国、02118
        • Ep0165 50615
    • Missouri
      • St Louis、Missouri、美国、63110
        • Ep0165 50507
    • New Jersey
      • New Brunswick、New Jersey、美国、08901
        • Ep0165 50299
    • New York
      • Amherst、New York、美国、14226
        • Ep0165 50497
      • New Hyde Park、New York、美国、11042
        • Ep0165 50625
      • New York、New York、美国、10016
        • Ep0165 50298
      • New York、New York、美国、10029
        • Ep0165 50490
      • New York、New York、美国、10075
        • Ep0165 50518
      • Rochester、New York、美国、14642
        • Ep0165 50034
    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Ep0165 50514
      • Durham、North Carolina、美国、27705
        • Ep0165 50715
    • Oregon
      • Portland、Oregon、美国、97239
        • Ep0165 50701
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Ep0165 50096
      • Philadelphia、Pennsylvania、美国、19107
        • Ep0165 50364
      • Philadelphia、Pennsylvania、美国、19140
        • Ep0165 50089
      • Pittsburgh、Pennsylvania、美国、15212
        • Ep0165 50511
      • Pittsburgh、Pennsylvania、美国、15213
        • Ep0165 50491
    • Tennessee
      • Chattanooga、Tennessee、美国、37403
        • Ep0165 50700
      • Memphis、Tennessee、美国、38103-2800
        • Ep0165 50513
      • Nashville、Tennessee、美国、37232
        • Ep0165 50103
    • Texas
      • Austin、Texas、美国、78749
        • Ep0165 50731
      • Houston、Texas、美国、77459
        • Ep0165 50525
      • Houston、Texas、美国、77030
        • Ep0165 50714
    • Utah
      • Salt Lake City、Utah、美国、84132
        • Ep0165 50473
    • Virginia
      • Winchester、Virginia、美国、22601
        • Ep0165 50726
  • 英国
      • Birmingham、英国
        • Ep0165 40686
      • Glasgow、英国
        • Ep0165 40735
      • London、英国
        • Ep0165 40833
      • Oxford、英国
        • Ep0165 40163
      • Salford、英国
        • Ep0165 40108
  • 西班牙
      • Barcelona、西班牙
        • Ep0165 40160
      • L'Hospitalet de Llobregat、西班牙
        • Ep0165 40157
      • Madrid、西班牙
        • Ep0165 40540
      • Pamplona、西班牙
        • Ep0165 40352
      • Seville、西班牙
        • Ep0165 40668
      • Terrassa、西班牙
        • Ep0165 40453
      • Valencia、西班牙
        • Ep0165 40230
      • Valladolid、西班牙
        • Ep0165 40667

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

  • Participant must be ≥12 years of age at the time of signing informed consent

  • Participant must have a study caregiver ≥18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant's seizures

  • Participants with an established diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of stereotypical episodes of prolonged seizures that includes at least 1 of the following:

    1. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
    2. Episodes of a focal seizure with a minimum duration of 3 minutes
    3. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes

  • Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))

Exclusion Criteria:

  • Participant has a current history of alcohol or drug use disorder, as defined in the Diagnostic and Statistical Manual of Mental Disorders 5, within the previous 1 year
  • Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparable drugs (and/or an investigational device) as stated in this protocol or to albuterol (or similar bronchospasm rescue medication if needed to meet country-specific requirements)
  • Participant has a history of convulsive (generalized tonic-clonic) status epilepticus in the 8 weeks prior to the Screening Visit
  • Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures
  • Participant has a clinically significant known airway hypersensitivity (eg, bronchospasm to known allergens, such as pollen, animals, or food) and/or acute respiratory signs/symptoms (eg, shortness of breath, wheezing on lung auscultation). NOTE: Participants with mild asthma who qualify for inclusion in the are allowed to be enrolled even though they have known airway hypersensitivity
  • Participant has a clinically significant chronic pulmonary disorder other than mild asthma (eg, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax
  • Participant has had a positive antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and experienced moderate to severe signs/symptoms of respiratory distress necessitating hospitalization or outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more, unless full resolution occurred at least 6 months prior to Screening
  • Participant has experienced a severe upper respiratory tract infection within 4 weeks or severe bronchitis/pneumonia within 3 months before the Screening Visit
  • Participant has a history or presence of acute narrow-angle glaucoma
  • Participant has a condition for which oral alprazolam is contraindicated as per the regional labeling
  • Participant is taking any drug that is a strong CYP3A4 inhibitor, including azole antifungal agents (ketoconazole and itraconazole) and nefazodone
  • Participant is taking any opioids or sedative hypnotics on a chronic basis
  • Participant is taking nonselective beta blockers on a chronic basis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：Staccato alprazolam

Participants will receive Staccato alprazolam by inhalation.
药品：Staccato alprazolam
  • Pharmaceutical form: Inhalation powder
  • Route of administration: Inhalation

Participants will receive Staccato alprazolam during the Treatment Period.

其他名称：
  • UCB7538

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Frequency of treatment-emergent adverse events (TEAEs)
大体时间：From Baseline up to the End of Study Visit (up to 78 months)

An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
From Baseline up to the End of Study Visit (up to 78 months)
Frequency of TEAEs leading to withdrawal from study
大体时间：From Baseline up to the End of Study Visit (up to 78 months)

An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
From Baseline up to the End of Study Visit (up to 78 months)
Frequency of serious TEAEs
大体时间：From Baseline up to the End of Study Visit (up to 78 months)

A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires inpatient hospitalisation or prolongation of existing hospitalisation
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly/birth defect
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
From Baseline up to the End of Study Visit (up to 78 months)

次要结果测量

结果测量
措施说明
大体时间
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
大体时间：From start of IMP treatment up to 12 months

A responder after up to a maximum of 10 treated seizures will be defined as having a termination of seizure within 90 seconds after IMP dministration.
From start of IMP treatment up to 12 months
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
大体时间：From start of IMP treatment up to 12 months

A responder after up to a maximum of 10 treated seizures will be defined as termination of seizure within 90 seconds after IMP administration and no recurrence of seizure(s) from IMP administration to 2 hours after IMP administration and no initiation of seizure rescue treatment from 90 seconds to 2 hours after IMP administration.
From start of IMP treatment up to 12 months
Frequency of respiratory TEAEs
大体时间：From Baseline up to the End of Study Visit (up to 78 months)

An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration.
From Baseline up to the End of Study Visit (up to 78 months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UCB Biopharma SRL

调查人员

  • 研究主任：UCB Cares、001 844 599 2273 (UCB)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年2月3日

初级完成 (估计的)

2028年11月30日

研究完成 (估计的)

2028年11月30日

研究注册日期

首次提交

2021年9月30日

首先提交符合 QC 标准的

2021年9月30日

首次发布 (实际的)

2021年10月13日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • EP0165
  • 2021-002637-42 (EudraCT编号)
  • 2023-508868-30 (注册表标识符：EU Clinical Trials)
  • U1111-1299-3027 (其他标识符：Universal Trial Number (UTN))
  • 2023 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD 共享时间框架

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD 共享访问标准

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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