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

Conditions

• Stereotypical Prolonged Seizures

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Staccato alprazolam — DRUG
  * Pharmaceutical form: Inhalation powder * Route of administration: Inhalation Participants will receive Staccato alprazolam during the Treatment Period.

Study Details

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

Key Dates

Start date

Feb 3, 2022

Status verified

May 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Staccato alprazolam
  Participants will receive Staccato alprazolam by inhalation.

Primary Outcome Measure

Frequency of treatment-emergent adverse events (TEAEs) [ Time Frame: From Baseline up to the End of Study Visit (up to 78 months) ]

Locations (53)

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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
  PHASE3 · Recruiting · UCB Biopharma SRL · Phoenix, Arizona