A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
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
4 other identifiers
interventional
300
12 countries
146
Brief Summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2022
Longer than P75 for phase_3
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedStudy Start
First participant enrolled
February 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
April 24, 2026
April 1, 2026
6.8 years
September 30, 2021
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Frequency of treatment-emergent adverse events (TEAEs)
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
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
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 above
From Baseline up to the End of Study Visit (up to 78 months)
Secondary Outcomes (3)
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
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
Frequency of respiratory TEAEs
From Baseline up to the End of Study Visit (up to 78 months)
Study Arms (1)
Staccato alprazolam
EXPERIMENTALParticipants will receive Staccato alprazolam by inhalation.
Interventions
* Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.
Eligibility Criteria
You may qualify if:
- 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:
- 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
- Prior to the Screening Visit, participant completed a study using Staccato alprazolam (such as EP0162 (NCT05077904), ENGAGE-E-001 (NCT03478982), or UP0100 (NCT04857307))
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (146)
Ep0165 50506
Phoenix, Arizona, 85004, United States
Ep0165 50720
Scottsdale, Arizona, 85254, United States
Ep0165 50494
Little Rock, Arkansas, 72205, United States
Ep0165 50118
Downey, California, 90242, United States
Ep0165 50416
La Jolla, California, 92037, United States
Ep0165 50702
Long Beach, California, 90806, United States
Ep0165 50722
Poway, California, 92064, United States
Ep0165 50716
Sacramento, California, 95817, United States
Ep0165 50367
New Haven, Connecticut, 06519, United States
Ep0165 50088
Washington D.C., District of Columbia, 20037, United States
Ep0165 50721
Boca Raton, Florida, 33486, United States
Ep0165 50515
Gulf Breeze, Florida, 32561, United States
Ep0165 50508
Jacksonville, Florida, 32209-6533, United States
Ep0165 50342
Jacksonville, Florida, 32224, United States
Ep0165 50199
Miami, Florida, 33136, United States
Ep0165 50676
Miami, Florida, 33176, United States
Ep0165 50509
Orlando, Florida, 32806, United States
Ep0165 50703
Rockledge, Florida, 32955, United States
Ep0165 50308
Tampa, Florida, 33606, United States
Ep0165 50323
Honolulu, Hawaii, 96817, United States
Ep0165 50512
Boise, Idaho, 83702, United States
Ep0165 50493
Chicago, Illinois, 60611, United States
Ep0165 50375
Springfield, Illinois, 62702, United States
Ep0165 50504
Fort Wayne, Indiana, 46804, United States
Ep0165 50517
New Orleans, Louisiana, 70122, United States
Ep0165 50615
Boston, Massachusetts, 02118, United States
Ep0165 50047
Boston, Massachusetts, 02215, United States
Ep0165 50507
St Louis, Missouri, 63110, United States
Ep0165 50626
Neptune City, New Jersey, 07753, United States
Ep0165 50299
New Brunswick, New Jersey, 08901, United States
Ep0165 50497
Amherst, New York, 14226, United States
Ep0165 50625
New Hyde Park, New York, 11042, United States
Ep0165 50298
New York, New York, 10016, United States
Ep0165 50490
New York, New York, 10029, United States
Ep0165 50518
New York, New York, 10075, United States
Ep0165 50034
Rochester, New York, 14642, United States
Ep0165 50514
Charlotte, North Carolina, 28204, United States
Ep0165 50715
Durham, North Carolina, 27705, United States
Ep0165 50724
Portland, Oregon, 97227, United States
Ep0165 50701
Portland, Oregon, 97239, United States
Ep0165 50096
Philadelphia, Pennsylvania, 19104, United States
Ep0165 50364
Philadelphia, Pennsylvania, 19107, United States
Ep0165 50089
Philadelphia, Pennsylvania, 19140, United States
Ep0165 50511
Pittsburgh, Pennsylvania, 15212, United States
Ep0165 50491
Pittsburgh, Pennsylvania, 15213, United States
Ep0165 50700
Chattanooga, Tennessee, 37403, United States
Ep0165 50513
Memphis, Tennessee, 38103-2800, United States
Ep0165 50103
Nashville, Tennessee, 37232, United States
Ep0165 50731
Austin, Texas, 78749, United States
Ep0165 50714
Houston, Texas, 77030, United States
Ep0165 50525
Houston, Texas, 77459, United States
Ep0165 50473
Salt Lake City, Utah, 84132, United States
Ep0165 50726
Winchester, Virginia, 22601, 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 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 20337
Shimotsuga-gun, 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 40833
London, United Kingdom
Ep0165 40163
Oxford, United Kingdom
Ep0165 40108
Salford, United Kingdom
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2021
First Posted
October 13, 2021
Study Start
February 3, 2022
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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.