Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05076617
Registration number
NCT05076617
Ethics application status
Date submitted
30/09/2021
Date registered
13/10/2021
Date last updated
21/06/2024
Titles & IDs
Public title
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
2021-002637-42
Query!
Secondary ID [2]
0
0
EP0165
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Stereotypical Prolonged Seizures
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Epilepsy
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Staccato alprazolam
Experimental: Staccato alprazolam - Participants will receive Staccato alprazolam by inhalation.
Treatment: Drugs: Staccato alprazolam
* Pharmaceutical form: Inhalation powder
* Route of administration: Inhalation
Participants will receive Staccato alprazolam during the Treatment Period.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Frequency of treatment-emergent adverse events (TEAEs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From Baseline up to the End of Study Visit (up to 48 months)
Query!
Primary outcome [2]
0
0
Frequency of TEAEs leading to withdrawal from study
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From Baseline up to the End of Study Visit (up to 48 months)
Query!
Primary outcome [3]
0
0
Frequency of serious TEAEs
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
From Baseline up to the End of Study Visit (up to 48 months)
Query!
Secondary outcome [1]
0
0
Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From start of IMP treatment up to 12 months
Query!
Secondary outcome [2]
0
0
Treatment success after IMP administration with no recurrence after 2 hours for seizures during the first 12 months
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From start of IMP treatment up to 12 months
Query!
Secondary outcome [3]
0
0
Frequency of respiratory TEAEs
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From Baseline up to the End of Study Visit (up to 48 months)
Query!
Eligibility
Key inclusion criteria
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))
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
* 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/02/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/05/2026
Query!
Actual
Query!
Sample size
Target
300
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Ep0165 30016 - Fitzroy
Query!
Recruitment hospital [2]
0
0
Ep0165 30030 - Herston
Query!
Recruitment hospital [3]
0
0
Ep0165 30027 - Melbourne
Query!
Recruitment hospital [4]
0
0
Ep0165 30031 - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [2]
0
0
- Herston
Query!
Recruitment postcode(s) [3]
0
0
- Melbourne
Query!
Recruitment postcode(s) [4]
0
0
- South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Hawaii
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Idaho
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Massachusetts
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Jersey
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Utah
Query!
Country [25]
0
0
Bulgaria
Query!
State/province [25]
0
0
Blagoevgrad
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Pazardzhik
Query!
Country [27]
0
0
Bulgaria
Query!
State/province [27]
0
0
Pleven
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Sofia
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Beijing
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Changchun
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Chengdu
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Chongqing
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Guangzhou
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Hangzhou
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Lanzhou
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Nanjing
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Shanghai
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Shijiazhuang
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Suzhou
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Tianjin
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Wenzhou
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Wuhan
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Yinchuan
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Zhanjiang
Query!
Country [45]
0
0
China
Query!
State/province [45]
0
0
Zhengzhou
Query!
Country [46]
0
0
Czechia
Query!
State/province [46]
0
0
Brno
Query!
Country [47]
0
0
Czechia
Query!
State/province [47]
0
0
Ostrava - Poruba
Query!
Country [48]
0
0
Czechia
Query!
State/province [48]
0
0
Praha 4
Query!
Country [49]
0
0
Czechia
Query!
State/province [49]
0
0
Praha 5
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Praha 6
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Berlin
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Bielefeld
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Erlangen
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Frankfurt
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Kehl
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Marburg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
München
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Balassagyarmat
Query!
Country [59]
0
0
Hungary
Query!
State/province [59]
0
0
Budapest
Query!
Country [60]
0
0
Hungary
Query!
State/province [60]
0
0
Debrecen
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Catanzaro
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Genova
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Milano
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Pavia
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Roma
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Fukuoka
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Hamamatsu
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Hiroshima
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Hofu
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Itami
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Kodaira
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Koshi
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Nagakute
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Niigata
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Omura
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Osaka
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Sapporo
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Shinjuku-ku
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Shizuoka
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Suita
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Toon
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Yamagata
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Bydgoszcz
Query!
Country [84]
0
0
Poland
Query!
State/province [84]
0
0
Gdansk
Query!
Country [85]
0
0
Poland
Query!
State/province [85]
0
0
Krakow
Query!
Country [86]
0
0
Poland
Query!
State/province [86]
0
0
Lublin
Query!
Country [87]
0
0
Poland
Query!
State/province [87]
0
0
Nowa Sol
Query!
Country [88]
0
0
Poland
Query!
State/province [88]
0
0
Swidnik
Query!
Country [89]
0
0
Spain
Query!
State/province [89]
0
0
Barcelona
Query!
Country [90]
0
0
Spain
Query!
State/province [90]
0
0
Hospitalet de Llobregat
Query!
Country [91]
0
0
Spain
Query!
State/province [91]
0
0
Madrid
Query!
Country [92]
0
0
Spain
Query!
State/province [92]
0
0
Pamplona
Query!
Country [93]
0
0
Spain
Query!
State/province [93]
0
0
Sevilla
Query!
Country [94]
0
0
Spain
Query!
State/province [94]
0
0
Terrassa
Query!
Country [95]
0
0
Spain
Query!
State/province [95]
0
0
Valencia
Query!
Country [96]
0
0
Spain
Query!
State/province [96]
0
0
Valladolid
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Birmingham
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Cardiff
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Oxford
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Salford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
UCB Biopharma SRL
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05076617
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Cares
Query!
Address
0
0
001 844 599 2273 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05076617
Download to PDF