Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures

Are you eligible to participate in this study?

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

  • Conditions:
    Epilepsy
  • Age: Between 12 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participant has diagnosis of focal or generalized epilepsy or combined focal and generalized epilepsy with a documented history of predictable episodes of prolonged seizures.
    2. Participant has experienced at least 4 predictable episodes of prolonged seizures in the past 6 months, and the last 2 predictable episodes of prolonged seizures must have occurred within the past 3 months.
    3. Participant has had a documented brain computerized tomography or magnetic resonance imaging review, performed after diagnosis of epilepsy and within the past 5 years that confirms the absence of a progressive neurological disorder.
    4. Participant is receiving a regimen of ASD(s) that has been stable (ie, no changes in the type of ASD) for the past 30 days.
    5. If male, participant must agree to use contraception during the treatment period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period.
    6. If female, participants must not be pregnant or breastfeeding, and at least 1 of the following conditions must apply:
      • Not a woman of childbearing potential (WOCBP), OR;
      • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 33 days after administering the study treatment.
    7. Participant is capable of giving signed informed consent or assent if a minor.
    8. The participant’s caregiver(s) must be capable of giving signed informed consent and able to comply with the study requirements and restrictions.

You may not be eligible for this study if the following are true:

    1. Participant has any medical or psychiatric condition that could jeopardize or would compromise the study participant’s ability to participate in this study.
    2. Participant has a current history of alcohol or drug use disorder within the previous 1 year.
    3. Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol or to albuterol.
    4. Participant has a diagnosis of atrial fibrillation or mitral stenosis.
    5. Participant has a history of status epilepticus in the past 6 months.
    6. Participant has a history or presence of known nonepileptic seizures which cannot be distinguished from qualifying epileptic seizures.
    7. Participant has clinically significant known airway hypersensitivity and/or acute respiratory signs/symptoms (eg, wheezing).
    8. Participant has a clinically significant chronic pulmonary disorder (eg, asthma, chronic obstructive pulmonary disease, and restrictive lung diseases including idiopathic pulmonary fibrosis) and/or recent history or presence of hemoptysis or pneumothorax.
    9. Participant has had a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or clinical signs/symptoms consistent with coronavirus disease (COVID-19) such as fever, persistent cough, shortness of breath, fatigue, loss or change to senses of smell or taste, during the past 4 weeks.
    10. Participant has had a positive test for SARS-CoV-2 and experienced moderate to severe signs/symptoms of respiratory distress necessitating outpatient treatment such as ambulatory oxygen, extensive treatment with inhaler medications, and/or oral medications for a duration of 4 weeks or more.
    11. Participant experienced a severe course of COVID-19 that had required hospitalization.
    12. Participant has a history or presence of acute narrow-angle glaucoma.
    13. Participant has a condition for which oral alprazolam is contraindicated (eg, myasthenia gravis, severe respiratory insufficiency, sleep apnea syndrome, and severe hepatic insufficiency).
    14. Positive human immunodeficiency virus antibody test.
    15. Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment.
    16. Participant has a history or presence of long QT syndrome, a family history of sudden death due to long QT syndrome, or unexplained syncope.
    17. Participant has a lifetime history of suicide attempt.
    18. Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be allowed for only 30% of study participants.
    19. Participant is taking any drug that significantly influences the metabolism of alprazolam (strong cytochrome P450 [CYP] 3A inhibitors including azole antifungal agents [ketoconazole and itraconazole], nefazodone).
    20. Participant is taking any opioids (eg, fentanyl, oxycodone, morphine) or sedative hypnotics on a chronic basis.
    21. Participant is taking pharmacotherapy for an active major psychiatric disorder where major changes in regimen are needed or anticipated during the study.
    22. Participant is currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the settings have not changed within past 30 days.
    23. Participant is taking non-selective beta blockers (eg, propranolol, nadolol, and timolol) on a chronic basis.
    24. Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study.
    25. Participant has participated in another study of an IMP (and/or an investigational device) within the past 30 days or is currently participating in another study of an IMP (and/or an investigational device).
    26. Participant has presence of any sign (clinical or imaging techniques) suggesting rapidly progressing (ie, not expected to stay stable during study participation) brain disorder or brain tumor, as per Investigator. Stable arteriovenous malformations, meningiomas, or other benign tumors may be acceptable.
    27. Participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
    28. Positive urine screen for drugs of abuse at Screening (positive cannabis/cannabinol results are acceptable if there is a documented history of stable use for medical purposes).
    29. Participant has a blood pressure (BP) or heart rate (HR) outside the normal range after 5 minutes rest (systolic BP: 90mmHg to 150mmHg; diastolic BP: 40mmHg to 95mmHg; HR: 40bpm to 100bpm).
    30. Participant cannot actuate the practice “dummy” device during training.
    31. Participant who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the stability or capability of the participant to comply with the study requirements.
    32. Participant has any scheduled elective surgeries/procedures that might interfere with his/her study participation.
    33. Participant is using tetrahydrocannabinol-containing e-cigarette or vaping products, or e-cigarette or vaping products that contain vitamin E acetate.



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