A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Condition(s) studied
Investigational drug(s) / intervention(s)
Staccato alprazolam: * Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.
Study summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Eligibility
Primary outcome measure(s)
- Frequency of treatment-emergent adverse events (TEAEs) — From Baseline up to the End of Study Visit (up to 78 months)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration. - Frequency of TEAEs leading to withdrawal from study — From Baseline up to the End of Study Visit (up to 78 months)
An Adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medical product (IMP) and whether anticipated or unanticipated. A treatment-emergent adverse event (TEAE) is defined as any AE with a start date/time on or after the first IMP administration. - Frequency of serious TEAEs — From Baseline up to the End of Study Visit (up to 78 months)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability/incapacity, or * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Trial sites (136)
| Facility | City | Region | Status |
|---|---|---|---|
| Ep0165 50506 | Phoenix | Arizona | |
| Ep0165 50720 | Scottsdale | Arizona | |
| Ep0165 50494 | Little Rock | Arkansas | |
| Ep0165 50118 | Downey | California | |
| Ep0165 50416 | La Jolla | California | |
| Ep0165 50702 | Long Beach | California | |
| Ep0165 50722 | Poway | California | |
| Ep0165 50716 | Sacramento | California | |
| Ep0165 50088 | Washington D.C. | District of Columbia | |
| Ep0165 50515 | Gulf Breeze | Florida | |
| Ep0165 50508 | Jacksonville | Florida | |
| Ep0165 50342 | Jacksonville | Florida | |
| Ep0165 50199 | Miami | Florida | |
| Ep0165 50676 | Miami | Florida | |
| Ep0165 50509 | Orlando | Florida | |
| Ep0165 50703 | Rockledge | Florida | |
| Ep0165 50308 | Tampa | Florida | |
| Ep0165 50323 | Honolulu | Hawaii | |
| Ep0165 50512 | Boise | Idaho | |
| Ep0165 50493 | Chicago | Illinois | |
| Ep0165 50504 | Fort Wayne | Indiana | |
| Ep0165 50517 | New Orleans | Louisiana | |
| Ep0165 50615 | Boston | Massachusetts | |
| Ep0165 50047 | Boston | Massachusetts | |
| Ep0165 50507 | St Louis | Missouri | |
| Ep0165 50299 | New Brunswick | New Jersey | |
| Ep0165 50497 | Amherst | New York | |
| Ep0165 50625 | New Hyde Park | New York | |
| Ep0165 50298 | New York | New York | |
| Ep0165 50490 | New York | New York | |
| Ep0165 50518 | New York | New York | |
| Ep0165 50034 | Rochester | New York | |
| Ep0165 50514 | Charlotte | North Carolina | |
| Ep0165 50715 | Durham | North Carolina | |
| Ep0165 50701 | Portland | Oregon | |
| Ep0165 50096 | Philadelphia | Pennsylvania | |
| Ep0165 50364 | Philadelphia | Pennsylvania | |
| Ep0165 50089 | Philadelphia | Pennsylvania | |
| Ep0165 50511 | Pittsburgh | Pennsylvania | |
| Ep0165 50491 | Pittsburgh | Pennsylvania |
+ 96 more sites — see the full list on the official registry below.
More UCB Biopharma SRL trials in Germany
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05076617 on ClinicalTrials.gov ↗ ← All trials in Germany