EUCTR2021-002686-18-IT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 200 人开始时间: 2021年9月30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
- 200
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 Visit
- •- Participant must have a caregiver >=18 years of age at the Screening Visit; the 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 minutes
- •b) Episodes of a focal seizure with a minimum duration of 3 minutes
- •c) Episodes of a focal seizure or myoclonic seizure 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
- •- 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) OR
- •ii) A WOCBP who agrees to follow the contraceptive 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 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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •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 history of convulsive 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 (eg,asthma, chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic pulmonary fibrosis]) and/or recent history or presence of hemoptysis or pneumothorax
- •- Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)
- •- 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 nefazodone
- •- Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis
- •- Participant is taking nonselective beta blockers (eg, propranolol, nadolol, and timolol) on a chronic basis
- •- Participant has an forced expiratory volume in 1 second (FEV1) <80 % of predicted FEV1 as measured via spirometry at the Screening Visit
- •- Participant has an oxygen saturation <95 % for greater than 30 seconds during the Screening Visit
- •- Participant cannot actuate the Staccato training device at the Screening Visit and the Baseline/Randomization Visit
研究者
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