EUCTR2021-002637-42-PL进行中（未招募）1 期
An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability 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 300 人开始时间: 2021年11月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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 time of signing informed consent (or giving assent, where required)
- •- 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
- •- 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 minutes
- •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 completed a study using Staccato alprazolam
- •- Male and female participants:
- •a) A male participant must agree to use contraception during the Treatment Period and for at least 7 days after investigational medicinal product (IMP) administration
- •b) A female participant is eligible to participate if she is not pregnant, not breastfeeding, and:
- •i) Not a woman of childbearing potential (WOCBP)
- •ii) A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after IMP administration
- •- Participant is capable of giving signed informed consent (or giving assent, where required).
- •The informed consent form (ICF) or a specific assent form, where required, will be signed and dated by minors
- •- The participant’s caregiver(s) must be capable of giving signed informed, which includes compliance with the requirements and restrictions listed in the ICF, the protocol, and the individualized participant management plan (iPMP)
- •Additional inclusion criteria for treatment arms 2 to 5:
- •Prior to the Screening Visit, the participant completed the Phase 3
- •efficacy study with Staccato alprazolam (EP0162) at a clinical site
- •located in the EU, UK, and UA, and experienced an IMP-treated seizure
- •during the Outpatient Treatment Period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 49
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 236
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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
- •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)
- •- 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 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
- •(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
- •- 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
研究者
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