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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

William Tatum, D.O.

Open for enrollment

Contact information:

Doriana Boro

Boro.Doriana@mayo.edu

More information

Publications

Publications are currently not available