Treatment of stereotypical prolonged seizure
Conditions
Interventions
Product Name: Staccato alprazolam
Product Code: UCB7538
Pharmaceutical Form: Inhalation powder
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participant must be 12 to 17 years of age inclusive, at the time of signing the Informed Consent form (ICF) and the Assent form -Participant has an established diagnosis of focal, generalized, or focal and generalized epilepsy -Participant is in good general health as determined by medical evaluation including medical history and physical examination -Participants with a body weight =29 kg and body mass index (BMI) within the range 14 to 32 kg/m^2 (inclusive) -A male participant must agree to use contraception -A female participant is eligible to participate if she is not pregnant -Participant is capable of and provides assent, and the study participant's parent/legal representative provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the ICF, Assent form, and in this protocol -Participant has a lifetime history of never smoking >5 cigarettes/day, and a current history (for at least 6 months prior to Screening Visit) of not smoking at all (including e-cigarette and vaping products) -Participant has forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) >80% predicted at Screening. In case of an out-of-range result, 1 repeat test will be allowed. If the readings are out-of-range again, the study participant will be excluded -Participant is willing and able to be confined to a clinical research facility for up to 36 hours (including 1 overnight stay) and comply with the study schedule and study requirements. Note: If there are no clinical contraindications, as per Investigator's judgment, study participants may leave the clinical research facility after the 6-hour postdose assessments and return to the clinic on Day 2 for the 24-hour and 36-hour postdose assessments -Participant is currently taking at least 1 background antiepileptic drug (AED) -Participant is able to actuate the training device during Screening, according to Instructions for Use Are the trial subjects under 18? yes Number of subjects for this age range: 14 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: -Participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, hematological, cerebrovascular, or other major disorders capable of significantly altering the absorption, metabolism, or elimination of Investigational Medicinal Product (IMP); constituting a risk when taking the study intervention; or interfering with the interpretation of data in the opinion of the Investigator -Participant has a known hypersensitivity to any components of the IMP or comparative drugs (and/or an investigational device) as stated in the protocol -Participant has severe chronic cardio-respiratory disease -Participant has history of acute narrow angle glaucoma, hydrocephalus, or Myasthenia Gravis -Participant has history or has current airway disease such asthma, cystic fibrosis, or chronic obstructive pulmonary disease -Participant has any acute respiratory signs/symptoms (ie, wheezing) and active acute respiratory infection (or within 1 week of dosing) with exception of symptoms of mild rhinitis -Participant has a known hypersensitivity to albuterol or similar short-acting beta2-agonist (SABA) that may be used as rescue medication administered in response to potential bronchospasm -Participant is taking strong liver inducing agents (eg, phenytoin, phenobarbital, carbamazepine, and primidone) or strong Cytochrome P450 3A4 (CYP3A4) inhibitors -Participant has a SpO2 measured by pulse oximetry 30 seconds during the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the PK of alprazolam in adolescent study participants with epilepsy following single inhaled dose of Staccato alprazolam • To evaluate the safety and tolerability of Staccato alprazolam in adolescent study participants with epilepsy;Secondary Objective: Not applicable;Primary end point(s): 1. Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam 2. Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam 3. Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam 4. Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam 5. Percentage of participants with treatment-emergent adverse event (TEAEs) 6. Percentage of participants with serious treatment-emergent adverse event (serious TEAEs);Timepoint(s) of evaluation of this end point: 1: Plasma samples taken on Day 1 predose and then postdose at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours. 2: Plasma samples taken on Day 1 predose and then postdose at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours. 3: Plasma samples taken on Day 1 predose and then postdose at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours. 4: Plasma samples taken on Day 1 predose and then postdose at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose. 5: From baseline (Day 1) till end of Safety Follow-up (up to Day 9). 6: From baseline (Day 1) till end of Safety Follow-up (up to Day 9). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed