Epilepsy
Conditions
Interventions
Participants will receive Staccato alprazolam by inhalation.
Sponsors
Sasamoto Hiroshi
Eligibility
Sex/Gender
All
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 seizure 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Frequency of treatment-emergent adverse events (TEAEs) - Frequency of TEAEs leading to withdrawal from study - Frequency of serious TEAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| - Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months - Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months -Frequency of respiratory TEAEs | — |
Countries
AUSTRALIA, BULGARIA, CHINA, GERMANY, HUNGARY, ITALY, Japan, POLAND, SPAIN, UKRAINE, UNITED KINGDOM, UNITED STATES, ZECH REPUBLIC
Contacts
Public ContactGlobal Clinical Science & Operation
UCB Japan Co., Ltd.
Outcome results
None listed