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 (S.T.A.R.S.)

Research summary

This is a study of an investigational new drug device combination product of Staccato and alprazolam inhalation powder, called “Staccato® alprazolam”. Staccato alprazolam is a single-use, hand-held, portable device that delivers alprazolam in aerosol form (a fine spray) deep into the lungs through inhalation (breathing in). Alprazolam is a drug which acts on the brain and nerves to produce a calming effect. The purpose of this study is to assess the effect and safety of Staccato alprazolam in epilepsy patients with previous episodes of prolonged seizures. This study will compare Staccato alprazolam and Staccato placebo. For this, we will put participants into 2 groups. The group that participants will be placed in is selected by chance, like tossing a coin or drawing names out of a hat. About 50% of study participants will receive Staccato alprazolam and about 50% will receive Staccato placebo. The study will be conducted at hospitals and clinics, and will involve a minimum of 180 and a maximum of 250 study participants across countries and regions around the world including the US, Japan, Europe, and China. Participation in the study will last up to about 19 weeks (5 months). The study will consist of the following periods: • Screening Period: Includes the Screening Visit and the Baseline Visit (within 6 weeks after the Screening Visit). • Outpatient Treatment Period (up to 12 weeks): During this period, one qualifying prolonged seizure will be treated with the study drug. • Safety Follow-Up Period: During this period, no seizures will be treated with study drug. During the study, participants will undergo various tests and procedures that are outside of their usual standard of care. UCB Biopharma SRL is the sponsor of this study.

Principal Investigator

Arjune Sen

Contact us

Email: dendron@ouh.nhs.uk

IRAS number

304241