A Study to Test the Efficacy and Safety 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
  Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
• Placebo — OTHER
  Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.

Study Details

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.

Key Dates

Start date

Dec 7, 2021

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Staccato alprazolam Arm
  Participants randomized to this arm will receive a single dose of Staccato alprazolam by inhalation.
• Placebo Comparator: Placebo Arm
  Participants randomized to this arm will receive a single dose of placebo by inhalation.

Primary Outcome Measure

Treatment success for the treated seizure within 90 seconds after investigational medicinal product (IMP) administration [ Time Frame: From start of IMP treatment through 6 hours ]

Central Contacts

• UCB Cares
  1-844-599-2273 (USA)
  [email protected]
• UCB Cares
  0018445992273
  [email protected]

Locations (66)

Find similar trials in Phoenix, AZ

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