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

StatusEnrolling by Invitation

PhasePhase 3

SponsorUCB Biopharma SRL

Started2022-02-03

View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 89 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-08-13

Study Status, Contacts/Locations v88

Trial sites reduced: 140 → 137 locations

2026-07-30

Study Status, Contacts/Locations v87

Trial sites reduced: 146 → 140 locations

2026-07-02

Study Status v86

Re-verified, no change to tracked fields

2026-06-18

Study Status, Contacts/Locations v85

Study sitesdetails revised at 2 of 146 sites

2026-05-07

Study Status v84

Re-verified, no change to tracked fields

Show 45 earlier versions

2026-04-23

Study Status, Contacts/Locations v83

Study sites145→146

2026-04-09

Study Status v82

Re-verified, no change to tracked fields

2026-03-26

Study Status, Contacts/Locations v81

Study sites144→145

2026-03-12

Study Status, Contacts/Locations v80

Study sites143→144

2026-01-29

2 amendments v78-v79

2 re-verifications since 2026-01-15, no change to tracked fields

2025-12-18

Study Status, Contacts/Locations v77

Study sites141→143

2025-12-04

Study Status, Contacts/Locations v76

Study sites141 entries, revised

Ep0165 ~~20257~~50726

2025-11-20

Study Status, Contacts/Locations v75

Study sitesdetails revised at 2 of 141 sites

2025-11-06

Study Status, Contacts/Locations v74

Study sites139→141

2025-10-23

Study Status, Contacts/Locations v73

Study sites140→139

2025-10-08

Study Status, Outcome Measures, Eligibility v72

Eligibility criteria+29 characters

[...] has a condition for which oral alprazolam is contraindicated as per the regional labeling Participant is taking any drug that is a strong CYP3A4 inhi [...]

Secondary endpointsdetails revised at 1 of 3 entries

2025-08-28

Study Status, Contacts/Locations v71

Study sites139→140

2025-08-14

Study Status, Contacts/Locations v70

Study sites135→139

2025-07-31

Study Status, Contacts/Locations v69

Study sites143→135

2025-07-03

Study Status, Contacts/Locations v68

Study sites141→143

2025-06-19

Study Status, Contacts/Locations v67

Study sites140→141

2025-06-05

Study Status, Contacts/Locations v66

Study sites139→140

2025-05-22

Study Status, Contacts/Locations v65

Study sites138→139

2025-04-24

Study Status v64

Re-verified, no change to tracked fields

2025-03-12

Study Status, Contacts/Locations v63

Study sites137→138

2025-02-13

Study Identification, Study Status, Contacts/Locations v62

Study sites135→137

2025-01-30

Study Identification, Study Status, Contacts/Locations v61

Study sites132→135

2025-01-02

Study Status v60

Re-verified, no change to tracked fields

2024-11-21

Study Status, Contacts/Locations v59

Study sites129→132

2024-11-07

Study Status v58

Re-verified, no change to tracked fields

2024-10-10

Study Status, Contacts/Locations v57

Study sites136→129

2024-08-29

Study Status v56

Primary completion date2026-05-22→2028-11-30

Completion date2026-05-22→2028-11-30

2024-08-14

Study Status, Contacts/Locations v55

Study sites135→136

2024-08-01

Study Status v54

Re-verified, no change to tracked fields

2024-07-04

Study Status, Contacts/Locations v53

Study sites134→135

2024-06-20

Study Status, Contacts/Locations v52

Study sites133→134

2024-05-09

Study Status, Contacts/Locations v51

Study sites137→133

2024-04-25

Study Status, Contacts/Locations v50

Study sites136→137

2024-03-28

Study Status, Contacts/Locations v49

Study sitesdetails revised at 1 of 136 sites

2024-02-29

Study Status, Contacts/Locations v48

Study sitesdetails revised at 1 of 136 sites

2024-02-15

Study Status, Contacts/Locations v47

Study sites138→136

2024-01-18

Study Status, Contacts/Locations v46

Study sites139→138

2024-01-04

Study Status, Contacts/Locations v45

Study sites138→139

2023-12-19

Study Status, Contacts/Locations v44

Study sites137→138

2023-12-07

Study Status, Contacts/Locations v43

Study sites139→137

2023-11-23

Study Status, Contacts/Locations v42

Study sites138→139

2023-10-26

Study Status, Contacts/Locations v41

Study sites137→138

2023-09-28

Study Status, Contacts/Locations v40

Study sites135→137

2023-08-03

Study Status, Contacts/Locations v39

Study sites134→135

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 evaluate the long-term safety and tolerability of Staccato alprazolam.

Trial Details

NCT Number	NCT05076617
Lead Sponsor	UCB Biopharma SRL
Conditions	Stereotypical Prolonged Seizures
Enrollment	300 participants
Start Date	2022-02-03
Primary Completion	2028-11-30 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-09-25