Trials / Enrolling By Invitation
Enrolling By InvitationNCT05076617
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
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
- Enrolling By Invitation
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- UCB Biopharma SRL · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Staccato alprazolam | * Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period. |
Timeline
- Start date
- 2022-02-03
- Primary completion
- 2028-11-30
- Completion
- 2028-11-30
- First posted
- 2021-10-13
- Last updated
- 2026-04-13
Locations
145 sites across 12 countries: United States, Australia, Bulgaria, China, Czechia, Germany, Hungary, Italy, Japan, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05076617. Inclusion in this directory is not an endorsement.