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EP0165

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

Brief summary

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

Medical Condition

Stereotypical prolonged seizures

Min. Age

12
Years

Max. Age

-

Who Can Join?

All

Status

Enrolling by invitation
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: a) Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes b) Episodes of a focal seizure with a minimum duration of 3 minutes c) 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

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 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 and/or acute respiratory signs/symptoms - Participant has a clinically significant chronic pulmonary disorder and/or recent history or presence of hemoptysis or pneumothorax - Participant has ever been diagnosed with asthma (irrespective of current treatment) - 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 - Participant has a forced expiratory volume in 1 second (FEV1) <80 % of (FEV1) as measured via spirometry at the Screening Visit

Study Medication Description

Study Medication:

Staccato Alprazolam

Other Descriptive Name:

Staccato Alprazolam

Placebo

No

Comparator:

No

Study Dates

February 2022

Actual Start Date of Enrollment

August 2025

Planned Study Completion Date

General Information

Study ID:
EP0165
EudraCT Number:
2021-002637-42
CT.gov Number:
NCT05076617
Phase:
Phase 3

Interested in enrolling in our study?

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