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Clinical Trial Details

Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Study Description

Study EP0162 is a double-blind, randomized, placebo-controlled, multi-center, parallel-group, Phase 3 study to investigate the efficacy and safety of Staccato alprazolam in an outpatient setting in study participants with epilepsy who are 18 years of age and older and have stereotypical prolonged seizures.

This study is sponsored by UCB Biopharma SRL.

One qualifying prolonged seizure event per study participant will be treated with a single administration of an investigational medicinal product (IMP) in the outpatient setting.

Study participants will be randomized at a 1:1 ratio to receive Staccato alprazolam (2mg) or placebo for the treatment of the qualifying prolonged seizure event.

The study will be divided into 3 periods:
1. A Screening Period (including the Screening and Baseline/Randomization Visits),
2. An Outpatient Treatment Period, and
3. A Safety Follow-up (SFU) Period.

There will be a minimum of 4 in-person visits, with potential options of remote visits, and 1 phone call over a maximum period of 133 days (19 weeks).

There is a Safety Follow-up Period (SFP) (including an in-clinic SFU/Early Termination Visit (ET) Visit either within =5 to 12 days after IMP administration, after completion of the 12-week Outpatient Treatment Period without a qualifying prolonged seizure event, or as a consequence of early withdrawal/termination.

The study staff is available via phone or email to answer your questions if you are interested in the trial or would like to get more information about the study.

 

Open Enrollment
Contact Name: Layla Jamil
Contact Phone: (904) 244-9686
Contact Email: layla.jamil@jax.ufl.edu
Investigators

Principal Investigator
Suparna R. Krishnaiengar, M.B.B.S. (M.D.)
Neurology

Sub Investigator
Ramon E. Bautista, M.D., M.B.A.
Neurology

Sub Investigator
Katherine A. Zarroli, M.D.
Neurology