2023-508868-30-00招募中3 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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 42
- 主要终点
- 1. Frequency of treatment-emergent adverse events (TEAEs) 2. Frequency of TEAEs leading to withdrawal from study 3. Frequency of serious TEAEs
研究概览
简要总结
Evaluation of the long-term safety and tolerability of Staccato alprazolam.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
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 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.
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 syndrome) - Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope - 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 on a chronic basis
研究组 & 干预措施
alprazolam
Experimental
Participants receiving alprazolam
干预措施: alprazolam (Drug)
结局指标
主要结局
1. Frequency of treatment-emergent adverse events (TEAEs) 2. Frequency of TEAEs leading to withdrawal from study 3. Frequency of serious TEAEs
1. Frequency of treatment-emergent adverse events (TEAEs) 2. Frequency of TEAEs leading to withdrawal from study 3. Frequency of serious TEAEs
次要结局
- 1. Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months 2. Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months 3. Frequency of respiratory TEAEs
研究者
UCB Cares
Scientific
UCB Biopharma
研究点 (42)
Loading locations...
相似试验
Enrolling By Invitation
3 期
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged SeizuresStereotypical Prolonged SeizuresNCT05076617UCB Biopharma SRL300
招募中
3 期
An Open-Label Extension Study of Fazirsiran2023-503497-21-00Takeda Development Center Americas Inc.18
招募中
2 期
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept2024-516380-81-00Vera Therapeutics Inc.23
招募中
3 期
Study to Evaluate the Long-Term Efficacy and Safety of the Investigational Drug LIB003 for the Reduction of Cholesterol in Patients with Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease.2023-510057-41-00Lib Therapeutics LLC590
招募中
3 期
A study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALE)2023-504625-39-00Apellis Pharmaceuticals Inc.66