A new clinical trial from Engage Therapeutics might be right for you.
 
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What is this study about?

StATES is looking at how effective and safe orally-inhaled alprazolam (also known as STAP-001) is in people 18 years of age or older with focal or generalized epilepsy when given at the time of a seizure episode.

The following information will be gathered for each seizure episode and in the hours after the STAP-001 medication is given:

  • If seizure activity was stopped within two minutes of giving STAP-001
  • If seizures recurred within 2 to 12 hours after giving STAP-001
  • The seizure severity
  • If the seizure progressed to a complex partial (focal impaired awareness) or generalized tonic-clonic seizure

Participating in StATES will take place partly at an inpatient unit in a hospital. Participants will be admitted to a Clinical Research Unit (CRU) or an Epilepsy Monitoring Unit (EMU) for 2 to 8 days for the “treatment phase.” When they are hospitalized, they will be givin a one-time dose of either the study drug (STAP-001) or a placebo treatment after a seizure takes place. The rest of StATES is done after the person is discharged from the hospital.

Study Overview

Patients included in this study:

  • Age 18 years or older
  • Diagnosis of focal or generalized epilepsy
  • Documented history of predictable seizure episodes, that include at least one of the following:
    • Generalized seizure episodes that start with a flurry of absence seizures or myoclonic seizures that last at least 5 minutes
    • Episodes of prolonged focal seizures that last at least 3 minutes
    • Episodes of multiple (2 or more) focal seizures within a 2-hour time period
  • Able to provide personally signed and dated informed consent to participate in the study or will have a legally authorized representative sign the informed consent on their behalf

Study Duration

  • StATES is about 8 to 12 weeks long, including the screening and follow-up periods.

Enrollment is completed. Awaiting study results.