Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern
Status:
Completed
Trial end date:
2020-01-04
Target enrollment:
Participant gender:
Summary
This is a multi-center, double-blind, randomized, parallel group, dose-ranging study to
investigate the efficacy and clinical usability of STAP-001 in adult (18 years of age and
older) subjects with epilepsy with a predictable seizure pattern. These subjects have an
established diagnosis of focal or generalized epilepsy with a documented history of
predictable seizure episodes. This is an in-patient study. The subjects will be admitted to a
Clinical Research Unit (CRU) or Epilepsy Monitoring Unit (EMU) for study participation. The
duration of the stay in the in-patient unit will be 2-8 days. One seizure event per subject
will be treated with study medication. The duration and timing of the seizure event and
occurrence of subsequent seizures will be assessed by the Staff Caregiver(s)1 through
clinical observation and confirmed with video electroencephalogram (EEG).
Phase:
Phase 2
Details
Lead Sponsor:
Engage Therapeutics, Inc. EngageTherapeutics, Inc.