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 Baseline/Randomization Visit
- Participant must have a study caregiver ≥18 years of age at the Screening Visit; the
study caregiver(s) must be a relative, partner, friend, or legally authorized
representative (LAR) of the participant, or a person who provides daily care to the
participant and has a significant personal relationship with the participant; 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 has experienced ≥4 stereotypical episodes of
prolonged seizures in the past 6 months, and the last 2 stereotypical episodes of
prolonged seizures must have occurred within the 3 months prior to the Screening Visit
- Participant has had a documented brain computerized tomography or magnetic resonance
imaging review, performed after diagnosis of epilepsy and within the 5 years prior to
the Screening Visit, that confirms the absence of a progressive neurological disorder
- Participant is receiving a regimen of antiseizure medications (ASMs) that has been
stable (ie, no addition or removal of ASM[s]; dose adjustments are permitted to
ASM[s]; dose adjustments are not permitted for benzodiazepines) for 30 days prior to
the Screening Visit
- Male and female participants:
1. A male participant must agree to use contraception during the Outpatient
Treatment Period and for at least 7 days after IMP administration and refrain
from donating sperm during this period
2. A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and at least 1 of the following conditions applies:
i) Not a woman of childbearing potential (WOCBP) OR ii) A WOCBP who agrees to follow
the contraceptive guidance during the Outpatient Treatment Period and for at least 30
days after IMP administration
- Participant is capable of giving signed informed consent (or giving assent, where
required), which includes compliance with the requirements and restrictions listed in
the informed consent form (ICF), the protocol, and the individualized participant
management plan (iPMP). The ICF or a specific assent form, where required, will be
signed and dated by minors
- The participant's study caregiver(s) must be capable of giving signed informed
consent, which includes compliance with the requirements and restrictions listed in
the ICF, the protocol, and the iPMP
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 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 diagnosis of atrial fibrillation or mitral stenosis
- 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 (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)
- Participant has a clinically significant chronic pulmonary disorder (eg, asthma,
chronic obstructive pulmonary disease, restrictive lung diseases [including idiopathic
pulmonary fibrosis]) 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 (eg,
myasthenia gravis, severe respiratory insufficiency, and sleep apnea syndrome)
- Participant has a history or presence of long QT syndrome, a family history of sudden
death due to long QT syndrome, or unexplained syncope
- Chronic use of benzodiazepines for more than 3 days within a period of 7 days will be
allowed for approximately 30 % of study participants
- 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 (eg, fentanyl, oxycodone, morphine) or sedative
hypnotics on a chronic basis
- Participant is taking nonselective beta blockers (eg, propranolol, nadolol, and
timolol) on a chronic basis
- Participant is taking pharmacotherapy for an active major psychiatric disorder where
major changes in regimen are needed or anticipated during the study
- Participant has been treated with vagal nerve stimulation (VNS) for less than 6 months
or VNS settings have changed within 30 days before the Screening Visit
- Participant has a clinically significant laboratory abnormality that may increase the
risk associated with study participation or may interfere with the interpretation of
study results, according to the judgment of the Investigator
- Participant has an forced expiratory volume in 1 second (FEV1) <80 % of predicted FEV1
as measured via spirometry at the Screening Visit
- Participant has an oxygen saturation <95 % (or less than normal in regions of altitude
>2500 meters) for greater than 30 seconds during the Screening Visit. In case of an
out-of-range result, 1 repeat will be allowed. If the readings are out of range again,
the study participant will be excluded
- Participant has >2.0x upper limit of normal (ULN) of any of the following: alanine
aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP),
or >1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome or
>2.0xULN total bilirubin for liver impairment)
- Participant has current unstable liver or biliary disease per Investigator assessment
defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia,
esophageal or gastric varices, persistent jaundice, or cirrhosis
- Participant has a QT interval corrected for heart rate (QTc) >450 msec (males), QTc
interval >470 msec (females), or QTc interval >480 msec (participants with bundle
branch block), PR interval ≥220msec, or any other clinically significant
electrocardiogram (ECG) abnormality according to the Investigator i) The QTc is the QT
interval corrected for heart rate according to Fridericia's formula (QTcF). It is
either machine-read or manually over-read
- Participant has a positive urine screen for drugs of abuse at the Screening Visit
- Participant has a blood pressure (BP) or heart rate (HR) outside the following range
after 5 minutes rest: systolic BP: 90 mmHg to 150 mmHg; diastolic BP: 4 0mmHg to 95
mmHg; HR: 50 bpm to 100 bpm. In case of an out-of-range result, 1 repeat will be
allowed. If the readings are out of range again, the study participant will be
excluded