Enrolling by invitation 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

Phase III Interventional Stereotypical Prolonged Seizures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Staccato alprazolam.
Who it may be relevant to: Registry conditions: Stereotypical Prolonged Seizures. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Bulgaria, China, Czechia +7
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Interventions

Drug Staccato alprazolam
* Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.

Primary outcome measures

Frequency of treatment-emergent adverse events (TEAEs) [Time frame: From Baseline up to the End of Study Visit (up to 78 months)]
Frequency of TEAEs leading to withdrawal from study [Time frame: From Baseline up to the End of Study Visit (up to 78 months)]
Frequency of serious TEAEs [Time frame: From Baseline up to the End of Study Visit (up to 78 months)]

Secondary outcome measures (3)

Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months [Time frame: 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 [Time frame: From start of IMP treatment up to 12 months]
Frequency of respiratory TEAEs [Time frame: From Baseline up to the End of Study Visit (up to 78 months)]

Eligibility 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:

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))

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 49 centers

Ep0165 50506 — Phoenix
Ep0165 50720 — Scottsdale
Ep0165 50494 — Little Rock
Ep0165 50118 — Downey
Ep0165 50416 — La Jolla
Ep0165 50702 — Long Beach
Ep0165 50722 — Poway
Ep0165 50716 — Sacramento
… and 41 more centers

China · 25 centers

Ep0165 20246 — Beijing
Ep0165 20268 — Beijing
Ep0165 20299 — Beijing
Ep0165 20261 — Changchun
Ep0165 20133 — Chengdu
Ep0165 20137 — Chengdu
Ep0165 20334 — Chongqing
Ep0165 20179 — Fuzhou
… and 17 more centers

Japan · 19 centers