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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510950-29-00
Acronym
EP0162
Enrollment
126
Registered
2024-09-04
Start date
2022-07-21
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stereotypical prolonged seizure

Brief summary

Treatment success for the treated seizure with no recurrence after 2 hours

Detailed description

Treatment success for treated seizure with no recurrence after 4 hours, Treatment success for treated seizure with no recurrence after 6 hours, Time from IMP administration to cessation of the treated seizure, Frequency of respiratory treatment emergent adverse events (TEAEs), Number of subsequent seizure(s) up to 2 hours after IMP administration, Time to first subsequent seizure up to 2 hours after IMP administration

Interventions

DRUGalprazolam
DRUGPlacebo matching < Staccato® alprazolam > and without active substance

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Treatment success for the treated seizure with no recurrence after 2 hours—

Secondary

MeasureTime frame
Treatment success for treated seizure with no recurrence after 4 hours, Treatment success for treated seizure with no recurrence after 6 hours, Time from IMP administration to cessation of the treated seizure, Frequency of respiratory treatment emergent adverse events (TEAEs), Number of subsequent seizure(s) up to 2 hours after IMP administration, Time to first subsequent seizure up to 2 hours after IMP administration—

Countries

Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026