By InvitationPhase 3

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

United States300 participantsStarted 2022-02-03

Plain-language summary

The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam.

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Generalized seizure episodes starting with a flurry of absence seizures or myoclonic seizures with a minimum total duration of 5 minutes
✓. Episodes of a focal seizure with a minimum duration of 3 minutes
✓. Episodes of a focal seizure or a flurry of myoclonic seizures for at least 90 seconds followed by a generalized/bilateral tonic-clonic seizure with a minimum total duration of 3 minutes

Frequency of treatment-emergent adverse events (TEAEs)

Timeframe: From Baseline up to the End of Study Visit (up to 78 months)

Frequency of TEAEs leading to withdrawal from study

Timeframe: From Baseline up to the End of Study Visit (up to 78 months)

Frequency of serious TEAEs

Timeframe: From Baseline up to the End of Study Visit (up to 78 months)

NCT IDNCT05076617

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-11-30