Un estudio para evaluar la seguridad y la tolerabilidad de Staccato Alprazolam en participantes del estudio de 12 años de edad y mayores con convulsiones prolongadas estereotipadas
Un estudio abierto, multicéntrico y de extensión para pacientes ambulatorios para evaluar la seguridad y la tolerabilidad de Staccato Alprazolam en participantes del estudio de 12 años de edad y mayores con convulsiones prolongadas estereotipadas
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania
- Ep0165 40683
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Bielefeld, Alemania
- Ep0165 40685
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Erlangen, Alemania
- Ep0165 40023
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Frankfurt am Main, Alemania
- Ep0165 40645
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Marburg, Alemania
- Ep0165 40529
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Fitzroy, Australia
- Ep0165 30016
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Herston, Australia
- Ep0165 30030
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South Brisbane, Australia
- Ep0165 30031
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Blagoevgrad, Bulgaria
- Ep0165 40650
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Pazardzhik, Bulgaria
- Ep0165 40708
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Pleven, Bulgaria
- Ep0165 40665
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Sofia, Bulgaria
- Ep0165 40651
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Brno, Chequia
- Ep0165 40670
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Ostrava - Poruba, Chequia
- Ep0165 40672
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Prague, Chequia
- Ep0165 40063
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Prague, Chequia
- Ep0165 40671
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Prague, Chequia
- Ep0165 40714
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Barcelona, España
- Ep0165 40160
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L'Hospitalet de Llobregat, España
- Ep0165 40157
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Madrid, España
- Ep0165 40540
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Pamplona, España
- Ep0165 40352
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Seville, España
- Ep0165 40668
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Terrassa, España
- Ep0165 40453
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Valencia, España
- Ep0165 40230
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Valladolid, España
- Ep0165 40667
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
- Ep0165 50506
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Scottsdale, Arizona, Estados Unidos, 85253
- Ep0165 50720
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Ep0165 50494
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California
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Downey, California, Estados Unidos, 90242
- Ep0165 50118
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La Jolla, California, Estados Unidos, 92037
- Ep0165 50416
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Long Beach, California, Estados Unidos, 90806
- Ep0165 50702
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Poway, California, Estados Unidos, 92064
- Ep0165 50722
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Sacramento, California, Estados Unidos, 95817
- Ep0165 50716
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20037
- Ep0165 50088
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Florida
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Gulf Breeze, Florida, Estados Unidos, 32561
- Ep0165 50515
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Jacksonville, Florida, Estados Unidos, 32224
- Ep0165 50342
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Jacksonville, Florida, Estados Unidos, 32209-6533
- Ep0165 50508
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Miami, Florida, Estados Unidos, 33136
- Ep0165 50199
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Miami, Florida, Estados Unidos, 33176
- Ep0165 50676
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Orlando, Florida, Estados Unidos, 32806
- Ep0165 50509
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Rockledge, Florida, Estados Unidos, 32955
- Ep0165 50703
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Tampa, Florida, Estados Unidos, 33606
- Ep0165 50308
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96817
- Ep0165 50323
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Idaho
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Boise, Idaho, Estados Unidos, 83702
- Ep0165 50512
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Ep0165 50493
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46845
- Ep0165 50504
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70122
- Ep0165 50517
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Ep0165 50047
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Boston, Massachusetts, Estados Unidos, 02118
- Ep0165 50615
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Ep0165 50507
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Ep0165 50299
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New York
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Amherst, New York, Estados Unidos, 14226
- Ep0165 50497
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New Hyde Park, New York, Estados Unidos, 11042
- Ep0165 50625
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New York, New York, Estados Unidos, 10016
- Ep0165 50298
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New York, New York, Estados Unidos, 10029
- Ep0165 50490
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New York, New York, Estados Unidos, 10075
- Ep0165 50518
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Rochester, New York, Estados Unidos, 14642
- Ep0165 50034
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204
- Ep0165 50514
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Durham, North Carolina, Estados Unidos, 27705
- Ep0165 50715
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Ep0165 50701
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Ep0165 50096
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Ep0165 50364
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Ep0165 50089
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Ep0165 50511
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Ep0165 50491
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- Ep0165 50700
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Memphis, Tennessee, Estados Unidos, 38103-2800
- Ep0165 50513
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Nashville, Tennessee, Estados Unidos, 37232
- Ep0165 50103
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Texas
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Austin, Texas, Estados Unidos, 78749
- Ep0165 50731
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Houston, Texas, Estados Unidos, 77459
- Ep0165 50525
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Houston, Texas, Estados Unidos, 77030
- Ep0165 50714
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Utah
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Salt Lake City, Utah, Estados Unidos, 84132
- Ep0165 50473
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Virginia
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Winchester, Virginia, Estados Unidos, 22601
- Ep0165 50726
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Balassagyarmat, Hungría
- Ep0165 40666
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Budapest, Hungría
- Ep0165 40673
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Budapest, Hungría
- Ep0165 40704
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Debrecen, Hungría
- Ep0165 40653
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Genova, Italia
- Ep0165 40674
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Milan, Italia
- Ep0165 40144
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Pavia, Italia
- Ep0165 40477
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Roma, Italia
- Ep0165 40257
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Roma, Italia
- Ep0165 40675
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Fukuoka, Japón
- Ep0165 20248
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Hachioji-shi, Japón
- Ep0165 20070
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Hiroshima, Japón
- Ep0165 20249
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Hōfu, Japón
- Ep0165 20236
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Itami, Japón
- Ep0165 20239
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Kodaira, Japón
- Ep0165 20143
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Koshi-shi, Japón
- Ep0165 20315
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Kyoto, Japón
- Ep0165 20147
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Niigata, Japón
- Ep0165 20238
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Osaka, Japón
- Ep0165 20302
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Sapporo, Japón
- Ep0165 20316
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Shimotsuga-gun, Japón
- Ep0165 20337
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Shinjuku-ku, Japón
- Ep0165 20297
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Shizuoka, Japón
- Ep0165 20240
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Suita, Japón
- Ep0165 20242
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Tōon, Japón
- Ep0165 20266
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Yamagata, Japón
- Ep0165 20244
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Ōmura, Japón
- Ep0165 20241
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Bydgoszcz, Polonia
- Ep0165 40707
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Gdansk, Polonia
- Ep0165 40677
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Krakow, Polonia
- Ep0165 40842
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Lublin, Polonia
- Ep0165 40676
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Nowa Sól, Polonia
- Ep0165 40091
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Świdnik, Polonia
- Ep0165 40678
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Beijing, Porcelana
- Ep0165 20246
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Beijing, Porcelana
- Ep0165 20268
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Beijing, Porcelana
- Ep0165 20299
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Changchun, Porcelana
- Ep0165 20261
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Chengdu, Porcelana
- Ep0165 20133
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Chengdu, Porcelana
- Ep0165 20137
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Chongqing, Porcelana
- Ep0165 20334
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Fuzhou, Porcelana
- Ep0165 20179
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Guangzhou, Porcelana
- Ep0165 20264
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Guangzhou, Porcelana
- Ep0165 20269
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Guangzhou, Porcelana
- Ep0165 20124
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Guangzhou, Porcelana
- Ep0165 20300
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Hangzhou, Porcelana
- Ep0165 20022
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Kunming, Porcelana
- Ep0165 20320
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Lanzhou, Porcelana
- Ep0165 20258
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Nanjing, Porcelana
- Ep0165 20267
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Nanning, Porcelana
- Ep0165 20331
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Qingdao, Porcelana
- Ep0165 20333
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Shanghai, Porcelana
- Ep0165 20292
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Shijiazhuang, Porcelana
- Ep0165 20289
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Suzhou, Porcelana
- Ep0165 20119
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Tianjin, Porcelana
- Ep0165 20257
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Wenzhou, Porcelana
- Ep0165 20025
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Zhanjiang, Porcelana
- Ep0165 20262
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Zhengzhou, Porcelana
- Ep0165 20251
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Birmingham, Reino Unido
- Ep0165 40686
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Glasgow, Reino Unido
- Ep0165 40735
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London, Reino Unido
- Ep0165 40833
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Oxford, Reino Unido
- Ep0165 40163
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Salford, Reino Unido
- Ep0165 40108
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
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Participant must be ≥12 years of age at the time of signing informed consent
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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
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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:
- Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
- Episodes of a focal seizure with a minimum duration of 3 minutes
- 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
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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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Staccato alprazolam
Participants will receive Staccato alprazolam by inhalation. |
Participants will receive Staccato alprazolam during the Treatment Period.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Frequency of treatment-emergent adverse events (TEAEs)
Periodo de tiempo: From Baseline up to the End of Study Visit (up to 78 months)
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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. |
From Baseline up to the End of Study Visit (up to 78 months)
|
|
Frequency of TEAEs leading to withdrawal from study
Periodo de tiempo: From Baseline up to the End of Study Visit (up to 78 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. |
From Baseline up to the End of Study Visit (up to 78 months)
|
|
Frequency of serious TEAEs
Periodo de tiempo: From Baseline up to the End of Study Visit (up to 78 months)
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A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
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From Baseline up to the End of Study Visit (up to 78 months)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
Periodo de tiempo: From start of IMP treatment up to 12 months
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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. |
From start of IMP treatment up to 12 months
|
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Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
Periodo de tiempo: 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. |
From start of IMP treatment up to 12 months
|
|
Frequency of respiratory TEAEs
Periodo de tiempo: From Baseline up to the End of Study Visit (up to 78 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. |
From Baseline up to the End of Study Visit (up to 78 months)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: UCB Cares, 001 844 599 2273 (UCB)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- EP0165
- 2021-002637-42 (Número EudraCT)
- 2023-508868-30 (Identificador de registro: EU Clinical Trials)
- U1111-1299-3027 (Otro identificador: Universal Trial Number (UTN))
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Marco de tiempo para compartir IPD
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Criterios de acceso compartido de IPD
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .