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Само по покана Фаза 3 NCT05076617

A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Фаза 3 – широко изпитване преди одобрение
Заболявания: Stereotypical Prolonged Seizures

Спонсор: UCB Biopharma SRL

Налично на: БГ
Обобщение
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Кой може да участва
Inclusion criteria: * Participant must be ≥12 years of age at the time of signing informed consent * 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 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 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
Интервенции
Staccato alprazolam
DRUG
Места на провеждане 146
Австралия (3)
Ep0165 30016
Fitzroy
Ep0165 30030
Herston
Ep0165 30031
South Brisbane
България (5)
Ep0165 40650
Blagoevgrad
Ep0165 40708
Pazardzhik
Ep0165 40665
Pleven
Ep0165 40709
Pleven
Ep0165 40651
Sofia
Китай (25)
Ep0165 20246
Beijing
Ep0165 20268
Beijing
Ep0165 20299
Beijing
Ep0165 20261
Changchun
Ep0165 20133
Chengdu
Ep0165 20137
Chengdu
Ep0165 20334
Chongqing
Ep0165 20179
Fuzhou
Ep0165 20124
Guangzhou
Ep0165 20264
Guangzhou
Ep0165 20269
Guangzhou
Ep0165 20300
Guangzhou
Ep0165 20022
Hangzhou
Ep0165 20320
Kunming
Ep0165 20258
Lanzhou
Ep0165 20267
Nanjing
Ep0165 20331
Nanning
Ep0165 20333
Qingdao
Ep0165 20292
Shanghai
Ep0165 20289
Shijiazhuang
Ep0165 20119
Suzhou
Ep0165 20257
Tianjin
Ep0165 20025
Wenzhou
Ep0165 20262
Zhanjiang
Ep0165 20251
Zhengzhou
Чехия (5)
Ep0165 40670
Brno
Ep0165 40672
Ostrava - Poruba
Ep0165 40063
Prague
Ep0165 40671
Prague
Ep0165 40714
Prague
Германия (7)
Ep0165 40683
Berlin
Ep0165 40685
Bielefeld
Ep0165 40023
Erlangen
Ep0165 40645
Frankfurt am Main
Ep0165 40689
Kehl
Ep0165 40529
Marburg
Ep0165 40724
München
Унгария (4)
Ep0165 40666
Balassagyarmat
Ep0165 40673
Budapest
Ep0165 40704
Budapest
Ep0165 40653
Debrecen
Италия (5)
Ep0165 40674
Genova
Ep0165 40144
Milan
Ep0165 40477
Pavia
Ep0165 40257
Roma
Ep0165 40675
Roma
Япония (19)
Ep0165 20248
Fukuoka
Ep0165 20070
Hachioji-shi
Ep0165 20249
Hiroshima
Ep0165 20236
Hōfu
Ep0165 20239
Itami
Ep0165 20143
Kodaira
Ep0165 20315
Koshi-shi
Ep0165 20147
Kyoto
Ep0165 20243
Nagakute
Ep0165 20238
Niigata
Ep0165 20241
Ōmura
Ep0165 20302
Osaka
Ep0165 20316
Sapporo
Ep0165 20337
Shimotsuga-gun
Ep0165 20297
Shinjuku-ku
Ep0165 20240
Shizuoka
Ep0165 20242
Suita
Ep0165 20266
Tōon
Ep0165 20244
Yamagata
Полша (7)
Ep0165 40707
Bydgoszcz
Ep0165 40677
Gdansk
Ep0165 40502
Krakow
Ep0165 40842
Krakow
Ep0165 40676
Lublin
Ep0165 40091
Nowa Sól
Ep0165 40678
Świdnik
Испания (8)
Ep0165 40160
Barcelona
Ep0165 40157
L'Hospitalet de Llobregat
Ep0165 40540
Madrid
Ep0165 40352
Pamplona
Ep0165 40668
Seville
Ep0165 40453
Terrassa
Ep0165 40230
Valencia
Ep0165 40667
Valladolid
Великобритания (5)
Ep0165 40686
Birmingham
Ep0165 40735
Glasgow
Ep0165 40833
London
Ep0165 40163
Oxford
Ep0165 40108
Salford
САЩ (53)
Ep0165 50497
Amherst , New York
Ep0165 50731
Austin , Texas
Ep0165 50721
Boca Raton , Florida
Ep0165 50512
Boise , Idaho
Ep0165 50615
Boston , Massachusetts
Ep0165 50047
Boston , Massachusetts
Ep0165 50514
Charlotte , North Carolina
Ep0165 50700
Chattanooga , Tennessee
Ep0165 50493
Chicago , Illinois
Ep0165 50118
Downey , California
Ep0165 50715
Durham , North Carolina
Ep0165 50504
Fort Wayne , Indiana
Ep0165 50515
Gulf Breeze , Florida
Ep0165 50323
Honolulu , Hawaii
Ep0165 50714
Houston , Texas
Ep0165 50525
Houston , Texas
Ep0165 50508
Jacksonville , Florida
Ep0165 50342
Jacksonville , Florida
Ep0165 50416
La Jolla , California
Ep0165 50494
Little Rock , Arkansas
Ep0165 50702
Long Beach , California
Ep0165 50513
Memphis , Tennessee
Ep0165 50676
Miami , Florida
Ep0165 50199
Miami , Florida
Ep0165 50103
Nashville , Tennessee
Ep0165 50626
Neptune City , New Jersey
Ep0165 50299
New Brunswick , New Jersey
Ep0165 50367
New Haven , Connecticut
Ep0165 50625
New Hyde Park , New York
Ep0165 50517
New Orleans , Louisiana
Ep0165 50298
New York , New York
Ep0165 50490
New York , New York
Ep0165 50518
New York , New York
Ep0165 50509
Orlando , Florida
Ep0165 50096
Philadelphia , Pennsylvania
Ep0165 50364
Philadelphia , Pennsylvania
Ep0165 50089
Philadelphia , Pennsylvania
Ep0165 50506
Phoenix , Arizona
Ep0165 50511
Pittsburgh , Pennsylvania
Ep0165 50491
Pittsburgh , Pennsylvania
Ep0165 50724
Portland , Oregon
Ep0165 50701
Portland , Oregon
Ep0165 50722
Poway , California
Ep0165 50034
Rochester , New York
Ep0165 50703
Rockledge , Florida
Ep0165 50716
Sacramento , California
Ep0165 50473
Salt Lake City , Utah
Ep0165 50720
Scottsdale , Arizona
Ep0165 50375
Springfield , Illinois
Ep0165 50507
St Louis , Missouri
Ep0165 50308
Tampa , Florida
Ep0165 50088
Washington D.C. , District of Columbia
Ep0165 50726
Winchester , Virginia
Технически детайли
Статус
Само по покана
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Здрави доброволци
Не
Начална дата
03.02.2022
Крайна дата
30.11.2028
Регистрационен номер
NCT05076617
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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