EUCTR2021-002686-18-DE进行中（未招募）1 期
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
CB Biopharma SR0 个研究点目标入组 250 人开始时间: 2021年8月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •- Participant must be =12 years of age at the Baseline/Randomization
- •- Participant must have a study caregiver =18 years of age at the
- •Screening Visit; the study caregiver(s) must be a relative, partner,
- •friend, or legally authorized representative (LAR) of the participant, or a person who provides daily care to the participant and has a significant personal relationship with the participant; 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:
- •a) Generalized seizure episodes starting with a flurry of absence
- •seizures or myoclonic seizures with a minimum total duration of 5
- •b) Episodes of a focal seizure with a minimum duration of 3 minutes
- •c) 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 has experienced =4
- •stereotypical episodes of prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of prolonged seizures must have
- •occurred within the 3 months prior to the Screening Visit
- •- Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of
- •epilepsy and within the 5 years prior to the Screening Visit, that
- •confirms the absence of a progressive neurological disorder
- •- Participant is receiving a regimen of antiseizure medications (ASMs)
- •that has been stable (ie, no addition or removal of ASM[s]; dose
- •adjustments are permitted to ASM[s]; dose adjustments are not
- •permitted for benzodiazepines) for 30 days prior to the Screening Visit
- •- Male and female participants:
- •a) A male participant must agree to use contraception during the
- •Outpatient Treatment Period and for at least 7 days after investigational medicinal product (IMP) administration and refrain from donating sperm during this period
- •b) A female participant is eligible to participate if she is not pregnant,
- •not breastfeeding, and at least 1 of the following conditions applies:
- •i) Not a woman of childbearing potential (WOCBP)
- •ii) A WOCBP who agrees to follow the contraceptive guidance during
- •the Outpatient Treatment Period and for at least 30 days after IMP
- •administration
- •- Participant is capable of giving signed informed consent (or giving
- •assent, where required), which includes compliance with the
- •requirements and restrictions listed in the informed consent form (ICF), the protocol, and the individualized participant management plan (iPMP). The informed consent form (ICF), or a specific assent form, where required, will be signed and dated by minors
- •- The participant's study caregiver(s) must be capable of giving signed
- •informed consent), which includes compliance with the requirements
- •and restrictions listed in the ICF, the protocol, and the individualized
- •participant management plan (iPMP)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •- 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 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 diagnosis of atrial fibrillation or mitral stenosis
- •- 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)
- •- 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 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 an upper respiratory tract infection within
- •4 weeks or bronchitis/pneumonia within 3 months before the Screening
- •- Participant has a history or presence of acute narrow-angle glaucoma
- •- Participant has a condition for which oral alprazolam is contraindicated
- •(eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea
- •- Participant has a history or presence of long QT syndrome, a family
- •history of sudden death due to long QT syndrome, or unexplained
- •- Chronic use of benzodiazepines for more than 3 days within a period of
- •7 days will be allowed for approximately 30 % of study participants
- •- Participant is taking any drug that is a strong CYP3A4 inhibitor,
- •including azole antifungal agents (ketoconazole and itraconazole) and
- •- Participant is taking any opioids(eg, fentanyl, oxycodone, morphine) or
- •sedative hypnotics on a chronic basis
- •- Participant is taking nonselective beta blockers on a chronic basis
- •- Participant is taking pharmacotherapy for an active major psychiatric
- •disorder where major changes in regimen are needed or anticipated
- •during the study
- •- Participant has been treated with vagal nerve stimulation (VNS) for
- •less than 6 months or VNS settings have changed within 30 days before
- •the Screening Visit
- •- Participant has a clinically significant laboratory abnormality that may
- •increase the risk associated with study participation or may interfere
- •with the interpretation of study results, according to the judgment of the
- •Investigator
- •- Participant has an oxygen saturation <95 % (or less than normal in
- 另有 3 项未显示
研究者
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