Staccato Alprazolam for Seizures

Recruiting in Palo Alto (17 mi)

+160 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is studying the long-term safety and tolerability of Staccato alprazolam, a fast-acting inhaled medication for anxiety and panic disorders. Staccato alprazolam is a fast-acting inhaled formulation of alprazolam, which has been widely used and studied for its efficacy in treating anxiety and panic disorders.

Research Team

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Eligibility Criteria

This trial is for people aged 12 and older with focal or generalized epilepsy who have had prolonged seizures. They must have a caregiver to monitor them, no recent severe respiratory issues, no drug abuse in the past year, not be allergic to alprazolam or similar drugs, and should not take certain medications like strong CYP3A4 inhibitors.

Inclusion Criteria

I have been diagnosed with epilepsy and have a history of long-lasting seizures.

I have completed a study with Staccato alprazolam.

Participant must have a study caregiver ≥18 years of age at the time of signing the informed consent; the study caregiver(s) must be able to recognize and observe the participant's seizures

Exclusion Criteria

I have or had acute narrow-angle glaucoma.

I have mild asthma or other allergies affecting my breathing but can still participate.

I have had a major seizure episode in the last 8 weeks.

Treatment Details

Interventions

• Staccato alprazolam (Benzodiazepine)

Trial Overview The study tests Staccato alprazolam's long-term safety and tolerability in patients with epilepsy experiencing prolonged seizures. Participants previously involved in specific Staccato alprazolam studies are eligible.

Participant Groups

Group I: Staccato alprazolam Experimental Treatment 1 Intervention

Participants will receive Staccato alprazolam by inhalation.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven