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

Study on Safety and Tolerability of Investigational Medication for Seizures Lasting Longer Than Usual

M
Marlene Bultemeher

Primary Investigator

Enrolling By Invitation
12 years - 17 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

Invervention: Staccato alprazolam

  • Pharmaceutical form: Inhalation powder
  • Route of administration: Inhalation

Participants will receive Staccato alprazolam during the Treatment Period.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stereotypical Prolonged Seizures
  • Age: 12 years - 17 years
  • Gender: All

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
  • 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

This study investigates the safety and tolerability of an investigational medication for people aged 12 and older who experience prolonged seizures. Prolonged seizures are seizures that last longer than usual and can be dangerous if not treated. The investigational medication is taken by inhalation, which means breathing it in as a powder.

Participants in the study will receive the investigational medication during the treatment period. They will be closely monitored to see how their bodies respond to the medication, and to ensure it is safe and well-tolerated. The study does not change their existing treatment plans.

  • Who can participate: Participants must be 12 years or older and have a caregiver aged 18 or older. They should have a history of prolonged seizures associated with epilepsy and must have completed a prior study using the investigational medication.
  • Study details: Participants will take the investigational medication by inhalation. They will be monitored for safety and tolerability during the study. Enrollment is by invitation only.
Updated on 10 Mar 2026. Study ID: FWNC-UCB-STARS-EXTENSION, 25986
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only