S.T.A.R.S. Extension
Research type
Research Study
Full title
An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
IRAS ID
304242
Contact name
Catherine Carter
Contact email
Sponsor organisation
UCB Biopharma SRL
Eudract number
2021-002637-42
Clinicaltrials.gov Identifier
132755, IND Number:
Duration of Study in the UK
3 years, 6 months, 30 days
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).
The purpose of this study is to further assess the long-term effect and safety of Staccato alprazolam in epilepsy patients with previous episodes of prolonged seizures. Participants in this study will be treated on an outpatient basis with Staccato alprazolam. They will be treated with 2mg of Staccato alprazolam for a seizure that can be treated with Staccato alprazolam. Staccato alprazolam can be used a maximum of 5 times per month.
This study will involve no more than approximately 300 study participants across countries and regions around the world including the US, Japan, Europe, and China.
Participants may be eligible to take part if they have a specific type of epilepsy with previous episodes of prolonged seizures, and they have previously participated in a Staccato alprazolam parent study.
Participation in the study will be up to about 4 years.
The study consists of the following periods:
• Screening/Baseline Period: Includes the Screening Visit and the Baseline Visit (within 6 weeks after the Screening Visit).
• Treatment Period: Includes the following:
o Check-in phone or video calls
- Post administration phone or video calls
- Monthly check-in phone or video calls
- Semi-annual phone or video calls.
o Site visits
- Post administration site visits.
- Quarterly site visits.
- Semi-annual site visits.
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.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0375
Date of REC Opinion
5 Jan 2022
REC opinion
Further Information Favourable Opinion