AN OPEN-LABEL, MULTICENTER, OUTPATIENT EXTENSION STUDY TO EVALUATE THE SAFETY AND TOLERABILITY 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

CTIS2023-508868-30-00

Acronym

EP0165

Enrollment

111

Registered

2024-06-07

Start date

2022-09-26

Completion date

Unknown

Last updated

2025-08-04

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

Conditions

Treatment of stereotypical prolonged seizure

Brief summary

1. Frequency of treatment-emergent adverse events (TEAEs) 2. Frequency of TEAEs leading to withdrawal from study 3. Frequency of serious TEAEs

Detailed description

1. Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months 2. Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months 3. Frequency of respiratory TEAEs

Interventions

DRUGPlacebo matching Staccato® alprazolam and without active substance

DRUGalprazolam

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Frequency of treatment-emergent adverse events (TEAEs) 2. Frequency of TEAEs leading to withdrawal from study 3. Frequency of serious TEAEs	—

Secondary

Measure	Time frame
1. Treatment success after investigational medicinal product (IMP) administration for seizures occurring within the first 12 months 2. Treatment success after IMP administration with no recurrence after 2 hours for seizures occurring within first 12 months 3. Frequency of respiratory TEAEs	—

Countries

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

Outcome results

None listed

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