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A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05076617

Enrolling By InvitationPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Stereotypical Prolonged Seizures

Interventions: Staccato alprazolam

Countries: United States, Australia, Bulgaria, China, Czechia, Germany, Hungary, Italy

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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:

  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))

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

Locations (137)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Downey, California, United States
La Jolla, California, United States
Long Beach, California, United States
Poway, California, United States
Sacramento, California, United States
Washington D.C., District of Columbia, United States
Gulf Breeze, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Rockledge, Florida, United States
Tampa, Florida, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
Amherst, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
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