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A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

StatusRecruiting
PhasePhase 3
Started2021-12-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 3 updates Jul 31, 2026 → Oct 31, 2026
See other at-risk trials from UCB Biopharma SRL

Amendment history

The 50 most recent of 90 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-10
Study Status, Contacts/Locations v89
Primary completion pushed: 2026-09-30 → 2026-10-31
Completion pushed: 2026-09-30 → 2026-10-31
Study sitesdetails revised at 1 of 183 sites
2026-08-26
Study Status v88
Primary completion pushed: 2026-08-31 → 2026-09-30
Completion pushed: 2026-08-31 → 2026-09-30
2026-08-13
Study Status, Contacts/Locations v87
Study sitesdetails revised at 2 of 183 sites
2026-07-30
Study Status, Contacts/Locations v86
Primary completion pushed: 2026-07-31 → 2026-08-31
Completion pushed: 2026-07-31 → 2026-08-31
Study sitesdetails revised at 5 of 183 sites
2026-06-30
Study Status v85
Primary completion pushed: 2026-06-30 → 2026-07-31
Completion pushed: 2026-06-30 → 2026-07-31
2026-06-18
Study Status, Contacts/Locations v84
Study sitesdetails revised at 5 of 183 sites
2026-05-18
Study Status, Contacts/Locations v83
Primary completion pushed: 2026-04 → 2026-06-30
Completion pushed: 2026-04 → 2026-06-30
Study sitesdetails revised at 2 of 183 sites
2026-04-24
Study Status, Contacts/Locations v82
Study sites182→183
2026-04-10
Study Status v81
Primary completion date2026-04-06→2026-04
Completion date2026-04-06→2026-04
2026-04-09
Study Status, Contacts/Locations v80
Primary completion date2026-04→2026-04-06
Completion date2026-04→2026-04-06
Study sitesdetails revised at 3 of 182 sites
2026-04-01
Study Status v79
Primary completion date2026-04-06→2026-04
Completion date2026-04-06→2026-04
2026-03-26
Study Status, Contacts/Locations v78
Study sites181→182
2026-03-12
Study Status, Contacts/Locations v77
Study sites180→181
2026-02-12
Study Status, Contacts/Locations v76
Study sitesdetails revised at 1 of 180 sites
2026-01-29
Study Status, Contacts/Locations v75
Study sitesdetails revised at 1 of 180 sites
2026-01-15
Study Status, Contacts/Locations v74
Study sitesdetails revised at 1 of 180 sites
2025-12-18
Study Status, Contacts/Locations v73
Study sites177→180
2025-12-04
Study Status, Contacts/Locations v72
Study sites177 entries, revised
Ep0162 2025750726
2025-11-20
Study Status, Contacts/Locations v71
Study sitesdetails revised at 2 of 177 sites
2025-11-06
Study Status, Contacts/Locations v70
Study sites175→177
2025-10-23
Study Status, Contacts/Locations v69
Study sites174→175
2025-09-11
Study Status, Contacts/Locations v68
Study sitesdetails revised at 1 of 174 sites
2025-08-28
Study Status, Contacts/Locations v67
Study sites173→174
2025-08-14
Study Status, Contacts/Locations v66
Study sites169→173
2025-07-31
Study Status, Contacts/Locations v65
Study sites166→169
2025-07-03
Study Status, Contacts/Locations v64
Study sites165→166
2025-06-19
Study Status, Contacts/Locations v63
Study sites164→165
2025-06-05
Study Status, Contacts/Locations v62
Study sites163→164
2025-05-22
Study Status, Contacts/Locations v61
Study sites162→163
2025-04-24
Study Status, Contacts/Locations v60
Study sitesdetails revised at 1 of 162 sites
2025-03-12
Study Status, Contacts/Locations v59
Study sites161→162
2025-02-13
Study Identification, Study Status, Contacts/Locations v58
Study sites160→161
2025-01-30
Study Status, Contacts/Locations v57
Study sites157→160
2025-01-20
Study Status, Study Design v56
Enrollment target250→350
2025-01-01
Study Status, Contacts/Locations v55
Study sitesdetails revised at 1 of 157 sites
2024-11-21
Study Status, Contacts/Locations v54
Study sites156→157
2024-11-14
Study Status, Contacts/Locations v53
Study sites154→156
2024-08-29
Study Status, Contacts/Locations v52
Primary completion date2024-04-17→2026-04-06
Completion date2024-04-17→2026-04-06
Study sites151→154
2024-04-11
Study Status v51
Re-verified, no change to tracked fields
2024-01-18
Study Status, Contacts/Locations v50
Study sitesdetails revised at 2 of 151 sites
2024-01-04
Study Status, Contacts/Locations v49
Study sites150→151
2023-12-19
Study Status, Contacts/Locations v48
Study sites149→150
2023-12-07
Study Status, Contacts/Locations v47
Study sites147→149
2023-10-26
Study Status, Contacts/Locations v46
Study sites146→147
2023-09-28
Study Status, Contacts/Locations v45
Study sites144→146
2023-08-17
Study Status, Contacts/Locations v44
Study sitesdetails revised at 2 of 144 sites
2023-08-03
Study Status, Contacts/Locations v43
Study sites143→144
2023-07-20
Study Status, Contacts/Locations v42
Study sites142→143
2023-07-06
Study Status, Contacts/Locations v41
Study sites141→142
2023-06-21
Study Status, Contacts/Locations v40
Study sites138→141
UCB Biopharma SRL
68 trials monitored
See 4 trials at risk
Epilepsy
723 trials monitored
See 41 trials at risk
The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.
Trial Details
NCT Number NCT05077904
Lead Sponsor UCB Biopharma SRL
Conditions Stereotypical Prolonged Seizures
Enrollment 350 participants
Start Date 2021-12-07
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-29