A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
- Registration Number
- NCT05076617
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 300
Not provided
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Staccato alprazolam Staccato alprazolam Participants will receive Staccato alprazolam by inhalation.
- Primary Outcome Measures
Name Time Method Frequency of treatment-emergent adverse events (TEAEs) From Baseline up to the End of Study Visit (up to 48 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.
Frequency of serious TEAEs From Baseline up to the End of Study Visit (up to 48 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 aboveFrequency of TEAEs leading to withdrawal from study From Baseline up to the End of Study Visit (up to 48 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.
- Secondary Outcome Measures
Name Time Method Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months 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.
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months 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.
Frequency of respiratory TEAEs From Baseline up to the End of Study Visit (up to 48 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.
Trial Locations
- Locations (138)
Ep0165 50511
🇺🇸Pittsburgh, Pennsylvania, United States
Ep0165 50491
🇺🇸Pittsburgh, Pennsylvania, United States
Ep0165 50513
🇺🇸Memphis, Tennessee, United States
Ep0165 50103
🇺🇸Nashville, Tennessee, United States
Ep0165 50525
🇺🇸Houston, Texas, United States
Ep0165 50473
🇺🇸Salt Lake City, Utah, United States
Ep0165 30016
🇦🇺Fitzroy, Australia
Ep0165 30030
🇦🇺Herston, Australia
Ep0165 30027
🇦🇺Melbourne, Australia
Ep0165 30031
🇦🇺South Brisbane, Australia
Ep0165 40650
🇧🇬Blagoevgrad, Bulgaria
Ep0165 40708
🇧🇬Pazardzhik, Bulgaria
Ep0165 40665
🇧🇬Pleven, Bulgaria
Ep0165 40709
🇧🇬Pleven, Bulgaria
Ep0165 40651
🇧🇬Sofia, Bulgaria
Ep0165 20128
🇨🇳Beijing, China
Ep0165 20246
🇨🇳Beijing, China
Ep0165 20268
🇨🇳Beijing, China
Ep0165 20299
🇨🇳Beijing, China
Ep0165 20261
🇨🇳Changchun, China
Ep0165 20133
🇨🇳Chengdu, China
Ep0165 20241
🇯🇵Omura, Japan
Ep0165 20302
🇯🇵Osaka, Japan
Ep0165 20137
🇨🇳Chengdu, China
Ep0165 20334
🇨🇳Chongqing, China
Ep0165 20179
🇨🇳Fuzhou, China
Ep0165 20124
🇨🇳Guangzhou, China
Ep0165 20260
🇨🇳Guangzhou, China
Ep0165 20264
🇨🇳Guangzhou, China
Ep0165 20269
🇨🇳Guangzhou, China
Ep0165 20300
🇨🇳Guangzhou, China
Ep0165 20316
🇯🇵Sapporo, Japan
Ep0165 20070
🇯🇵Shinjuku-ku, Japan
Ep0165 20297
🇯🇵Shinjuku-ku, Japan
Ep0165 20240
🇯🇵Shizuoka, Japan
Ep0165 20242
🇯🇵Suita, Japan
Ep0165 20266
🇯🇵Toon, Japan
Ep0165 20244
🇯🇵Yamagata, Japan
Ep0165 40707
🇵🇱Bydgoszcz, Poland
Ep0165 40677
🇵🇱Gdansk, Poland
Ep0165 40502
🇵🇱Krakow, Poland
Ep0165 40676
🇵🇱Lublin, Poland
Ep0165 40091
🇵🇱Nowa Sól, Poland
Ep0165 40678
🇵🇱Swidnik, Poland
Ep0165 40160
🇪🇸Barcelona, Spain
Ep0165 40157
🇪🇸Hospitalet de Llobregat, Spain
Ep0165 40540
🇪🇸Madrid, Spain
Ep0165 40352
🇪🇸Pamplona, Spain
Ep0165 40668
🇪🇸Sevilla, Spain
Ep0165 40453
🇪🇸Terrassa, Spain
Ep0165 40230
🇪🇸Valencia, Spain
Ep0165 40667
🇪🇸Valladolid, Spain
Ep0165 40686
🇬🇧Birmingham, United Kingdom
Ep0165 40300
🇬🇧Cardiff, United Kingdom
Ep0165 40163
🇬🇧Oxford, United Kingdom
Ep0165 40108
🇬🇧Salford, United Kingdom
Ep0165 20022
🇨🇳Hangzhou, China
Ep0165 20320
🇨🇳Kunming, China
Ep0165 20258
🇨🇳Lanzhou, China
Ep0165 20267
🇨🇳Nanjing, China
Ep0165 20331
🇨🇳Nanning, China
Ep0165 20333
🇨🇳Qingdao, China
Ep0165 20292
🇨🇳Shanghai, China
Ep0165 20332
🇨🇳Shenzhen, China
Ep0165 20289
🇨🇳Shijiazhuang, China
Ep0165 20119
🇨🇳Suzhou, China
Ep0165 20257
🇨🇳Tianjin, China
Ep0165 20025
🇨🇳Wenzhou, China
Ep0165 20255
🇨🇳Yinchuan, China
Ep0165 20262
🇨🇳Zhanjiang, China
Ep0165 20251
🇨🇳Zhengzhou, China
Ep0165 40670
🇨🇿Brno, Czechia
Ep0165 40672
🇨🇿Ostrava - Poruba, Czechia
Ep0165 40714
🇨🇿Praha 4, Czechia
Ep0165 40063
🇨🇿Praha 5, Czechia
Ep0165 40671
🇨🇿Praha 6, Czechia
Ep0165 40683
🇩🇪Berlin, Germany
Ep0165 40685
🇩🇪Bielefeld, Germany
Ep0165 40023
🇩🇪Erlangen, Germany
Ep0165 40645
🇩🇪Frankfurt, Germany
Ep0165 40689
🇩🇪Kehl, Germany
Ep0165 40529
🇩🇪Marburg, Germany
Ep0165 40724
🇩🇪München, Germany
Ep0165 40666
🇭🇺Balassagyarmat, Hungary
Ep0165 40144
🇮🇹Milano, Italy
Ep0165 40673
🇭🇺Budapest, Hungary
Ep0165 40704
🇭🇺Budapest, Hungary
Ep0165 40653
🇭🇺Debrecen, Hungary
Ep0165 40674
🇮🇹Genova, Italy
Ep0165 40477
🇮🇹Pavia, Italy
Ep0165 40257
🇮🇹Roma, Italy
Ep0165 40675
🇮🇹Roma, Italy
Ep0165 20248
🇯🇵Fukuoka, Japan
Ep0165 20237
🇯🇵Hamamatsu, Japan
Ep0165 20249
🇯🇵Hiroshima, Japan
Ep0165 20236
🇯🇵Hofu, Japan
Ep0165 20239
🇯🇵Itami, Japan
Ep0165 20143
🇯🇵Kodaira, Japan
Ep0165 20315
🇯🇵Koshi, Japan
Ep0165 20147
🇯🇵Kyoto, Japan
Ep0165 20243
🇯🇵Nagakute, Japan
Ep0165 20238
🇯🇵Niigata, Japan
Ep0165 50518
🇺🇸New York, New York, United States
Ep0165 50034
🇺🇸Rochester, New York, United States
Ep0165 50514
🇺🇸Charlotte, North Carolina, United States
Ep0165 50371
🇺🇸Akron, Ohio, United States
Ep0165 50528
🇺🇸Cleveland, Ohio, United States
Ep0165 50096
🇺🇸Philadelphia, Pennsylvania, United States
Ep0165 50364
🇺🇸Philadelphia, Pennsylvania, United States
Ep0165 50089
🇺🇸Philadelphia, Pennsylvania, United States
Ep0165 50506
🇺🇸Phoenix, Arizona, United States
Ep0165 50505
🇺🇸Los Angeles, California, United States
Ep0165 50494
🇺🇸Little Rock, Arkansas, United States
Ep0165 50118
🇺🇸Downey, California, United States
Ep0165 50492
🇺🇸Orange, California, United States
Ep0165 50367
🇺🇸New Haven, Connecticut, United States
Ep0165 50088
🇺🇸Washington, District of Columbia, United States
Ep0165 50515
🇺🇸Gulf Breeze, Florida, United States
Ep0165 50508
🇺🇸Jacksonville, Florida, United States
Ep0165 50342
🇺🇸Jacksonville, Florida, United States
Ep0165 50199
🇺🇸Miami, Florida, United States
Ep0165 50676
🇺🇸Miami, Florida, United States
Ep0165 50509
🇺🇸Orlando, Florida, United States
Ep0165 50308
🇺🇸Tampa, Florida, United States
Ep0165 50323
🇺🇸Honolulu, Hawaii, United States
Ep0165 50512
🇺🇸Boise, Idaho, United States
Ep0165 50493
🇺🇸Chicago, Illinois, United States
Ep0165 50375
🇺🇸Springfield, Illinois, United States
Ep0165 50504
🇺🇸Fort Wayne, Indiana, United States
Ep0165 50561
🇺🇸Lexington, Kentucky, United States
Ep0165 50517
🇺🇸New Orleans, Louisiana, United States
Ep0165 50047
🇺🇸Boston, Massachusetts, United States
Ep0165 50507
🇺🇸Saint Louis, Missouri, United States
Ep0165 50626
🇺🇸Neptune, New Jersey, United States
Ep0165 50299
🇺🇸New Brunswick, New Jersey, United States
Ep0165 50497
🇺🇸Amherst, New York, United States
Ep0165 50298
🇺🇸New York, New York, United States
Ep0165 50490
🇺🇸New York, New York, United States