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

Recruiting Phase 3 Interventional Study
Stereotypical Prolonged Seizures
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
UCB Biopharma SRL · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participant must be ≥12 years of age at the Baseline/Randomization Visit * Participant must have a study caregiver ≥18 years of age at the Screening Visit; the study caregiver(s) must be a relative, partner, friend, or legally authorized representative (LAR) of the participant…
Contacts

UCB Cares

1-844-599-2273 (USA)

UCBCares@ucb.com

CONTACT

UCB Cares

0018445992273

UCBCares@ucb.com

CONTACT