A Phase 1 interventional study of Alprazolam in Epilepsy, sponsored by UCB Biopharma SRL. Completed at 8 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Basic science
The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
The study participants will receive a single dose of Staccato alprazolam.
Drug: Alprazolam
* Pharmaceutical form: Inhalation powder. * Study participants will receive Staccato alprazolam at prespecified time-points.
Also known as: UCB7538
Maximum plasma concentration (Cmax) following single inhaled dose of Staccato alprazolam
Cmax = Maximum plasma concentration.
Time frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.
Area under the plasma concentration-time curve from zero to the last quantifiable concentration (AUC(0-t)) following single inhaled dose of Staccato alprazolam
AUC(0-t) = Area under the plasma concentration-time curve from zero to the last quantifiable concentration.
Time frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.
Area under the plasma concentration-time curve from time 0 to infinity (AUC) following single inhaled dose of Staccato alprazolam
AUC = Area under the plasma concentration-time curve from time 0 to infinity.
Time frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.
Apparent total body clearance (CL/F) following single inhaled dose of Staccato alprazolam
CL/F = Apparent total body clearance.
Time frame: Plasma samples will be taken on Day 1 of the Treatment Period, predose and then following administration of Investigational Medicinal Product (IMP) at 2 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 6 hours, 24 hours, and 36 hours postdose.
Percentage of participants with treatment-emergent adverse event (TEAEs)
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of IMP, whether or not considered related to the IMP.
Time frame: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)
Percentage of participants with serious treatment-emergent adverse event (serious TEAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: a. Results in death c. Requires inpatient hospitalization or prolongation of existing hospitalization d. Results in persistent disability/incapacity e. Is a congenital anomaly/birth defect f. Important medical events.
Time frame: From baseline (Day 1) till end of Safety Follow-up (up to Day 9)
Plan to share: No — Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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UCB Biopharma SRL