A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
NCT ID: NCT05076617
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
300 participants
INTERVENTIONAL
2022-02-03
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Staccato alprazolam
Participants will receive Staccato alprazolam by inhalation.
Staccato alprazolam
* Pharmaceutical form: Inhalation powder
* Route of administration: Inhalation
Participants will receive Staccato alprazolam during the Treatment Period.
Interventions
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Staccato alprazolam
* Pharmaceutical form: Inhalation powder
* Route of administration: Inhalation
Participants will receive Staccato alprazolam during the Treatment Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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'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:
1. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
2. Episodes of a focal seizure with a minimum duration of 3 minutes
3. 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 (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
Exclusion Criteria
* 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 as per the regional labeling
* 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
12 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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Ep0165 50506
Phoenix, Arizona, United States
Ep0165 50720
Scottsdale, Arizona, United States
Ep0165 50494
Little Rock, Arkansas, United States
Ep0165 50118
Downey, California, United States
Ep0165 50416
La Jolla, California, United States
Ep0165 50702
Long Beach, California, United States
Ep0165 50367
New Haven, Connecticut, United States
Ep0165 50088
Washington D.C., District of Columbia, United States
Ep0165 50721
Boca Raton, Florida, 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 50703
Rockledge, 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 50517
New Orleans, Louisiana, United States
Ep0165 50615
Boston, Massachusetts, United States
Ep0165 50047
Boston, Massachusetts, United States
Ep0165 50507
St Louis, Missouri, United States
Ep0165 50626
Neptune City, New Jersey, United States
Ep0165 50299
New Brunswick, New Jersey, United States
Ep0165 50497
Amherst, New York, United States
Ep0165 50625
New Hyde Park, New York, United States
Ep0165 50298
New York, New York, United States
Ep0165 50490
New York, New York, United States
Ep0165 50518
New York, New York, United States
Ep0165 50034
Rochester, New York, United States
Ep0165 50514
Charlotte, North Carolina, United States
Ep0165 50724
Portland, Oregon, United States
Ep0165 50096
Philadelphia, Pennsylvania, United States
Ep0165 50364
Philadelphia, Pennsylvania, United States
Ep0165 50089
Philadelphia, Pennsylvania, United States
Ep0165 50511
Pittsburgh, Pennsylvania, United States
Ep0165 50491
Pittsburgh, Pennsylvania, United States
Ep0165 50700
Chattanooga, Tennessee, United States
Ep0165 50513
Memphis, Tennessee, United States
Ep0165 50722
Nashville, Tennessee, United States
Ep0165 50103
Nashville, Tennessee, United States
Ep0165 50731
Austin, Texas, United States
Ep0165 50714
Houston, Texas, 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 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 20246
Beijing, , China
Ep0165 20268
Beijing, , China
Ep0165 20299
Beijing, , China
Ep0165 20261
Changchun, , China
Ep0165 20133
Chengdu, , China
Ep0165 20137
Chengdu, , China
Ep0165 20334
Chongqing, , China
Ep0165 20179
Fuzhou, , China
Ep0165 20124
Guangzhou, , China
Ep0165 20264
Guangzhou, , China
Ep0165 20269
Guangzhou, , China
Ep0165 20300
Guangzhou, , China
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 20262
Zhanjiang, , China
Ep0165 20251
Zhengzhou, , China
Ep0165 40670
Brno, , Czechia
Ep0165 40672
Ostrava - Poruba, , Czechia
Ep0165 40063
Prague, , Czechia
Ep0165 40671
Prague, , Czechia
Ep0165 40714
Prague, , Czechia
Ep0165 40683
Berlin, , Germany
Ep0165 40685
Bielefeld, , Germany
Ep0165 40023
Erlangen, , Germany
Ep0165 40645
Frankfurt am Main, , Germany
Ep0165 40689
Kehl, , Germany
Ep0165 40529
Marburg, , Germany
Ep0165 40724
München, , Germany
Ep0165 40666
Balassagyarmat, , Hungary
Ep0165 40673
Budapest, , Hungary
Ep0165 40704
Budapest, , Hungary
Ep0165 40653
Debrecen, , Hungary
Ep0165 40674
Genova, , Italy
Ep0165 40144
Milan, , Italy
Ep0165 40477
Pavia, , Italy
Ep0165 40257
Roma, , Italy
Ep0165 40675
Roma, , Italy
Ep0165 20248
Fukuoka, , Japan
Ep0165 20070
Hachioji-shi, , Japan
Ep0165 20249
Hiroshima, , Japan
Ep0165 20236
Hōfu, , Japan
Ep0165 20239
Itami, , Japan
Ep0165 20143
Kodaira, , Japan
Ep0165 20315
Koshi-shi, , Japan
Ep0165 20147
Kyoto, , Japan
Ep0165 20243
Nagakute, , Japan
Ep0165 20238
Niigata, , Japan
Ep0165 20302
Osaka, , Japan
Ep0165 20241
Ōmura, , Japan
Ep0165 20316
Sapporo, , Japan
Ep0165 20297
Shinjuku-ku, , Japan
Ep0165 20240
Shizuoka, , Japan
Ep0165 20242
Suita, , Japan
Ep0165 20266
Tōon, , Japan
Ep0165 20244
Yamagata, , Japan
Ep0165 40707
Bydgoszcz, , Poland
Ep0165 40677
Gdansk, , Poland
Ep0165 40502
Krakow, , Poland
Ep0165 40842
Krakow, , Poland
Ep0165 40676
Lublin, , Poland
Ep0165 40091
Nowa Sól, , Poland
Ep0165 40678
Świdnik, , Poland
Ep0165 40160
Barcelona, , Spain
Ep0165 40157
L'Hospitalet de Llobregat, , Spain
Ep0165 40540
Madrid, , Spain
Ep0165 40352
Pamplona, , Spain
Ep0165 40668
Seville, , Spain
Ep0165 40453
Terrassa, , Spain
Ep0165 40230
Valencia, , Spain
Ep0165 40667
Valladolid, , Spain
Ep0165 40686
Birmingham, , United Kingdom
Ep0165 40735
Glasgow, , United Kingdom
Ep0165 40163
Oxford, , United Kingdom
Ep0165 40108
Salford, , United Kingdom
Countries
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Other Identifiers
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2021-002637-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508868-30
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1299-3027
Identifier Type: OTHER
Identifier Source: secondary_id
EP0165
Identifier Type: -
Identifier Source: org_study_id