EP0165

The overall study objectives include evaluating the long-term safety and tolerability of Staccato alprazolam in patients with stereotypical prolonged epilepsy. The study will evaluate the probability of success of repeated treatment with Staccato alprazolam and of repeated treatment with Staccato alprazolam with no recurrence of seizure(s) up to 2 hours (for seizures occurring within the first 6 months [up to a maximum of 10 treated seizures]). Other objectives include evaluating the proportion of study participants who achieve REST100 and REST80 criteria after repeated Staccato alprazolam administration; evaluating the time from IMP administration to cessation of treated seizure(s) in study participants given Staccato alprazolam (for seizures occurring within the first 6 months/up to 10 treated seizures); evaluating the probability of success of repeated treatment with Staccato alprazolam with no recurrence of seizure(s) up to 4 and 6 hours (for seizures occurring within the first 6 months/up to 10 treated seizures); evaluating the proportion of study participants whose seizure fulfills one or more predefined criteria of seizure worsening or recurrence after treatment with Staccato alprazolam (for seizures occurring within the first 6 months/up to 10 treated seizures]); assessing the health-related quality of life and healthcare resource utilization following the use of Staccato alprazolam; assessing treatment satisfaction with the use of Staccato alprazolam; evaluating the frequency of seizures following the use of Staccato alprazolam; evaluating the potential for sedation and sleepiness following treatment with Staccato alprazolam; assessing the need for seizure rescue treatment, emergency room visit(s), emergency medical services, or hospital admissions following treatment with Staccato alprazolam; and assessing caregiver-reported respiration rate and oxygen saturation following treatment with Staccato alprazolam. The primary endpoints related to the primary objective (safety) include the frequency of treatment emergent adverse events (TEAEs), the frequency of TEAEs leading to study withdrawal, and frequency of serious TEAEs. With two secondary objectives related to efficacy, the endpoints are as follows: 1) treatment success after IMP administration for seizures occurring within the first 6 months (up to 10 maximum treated seizures) with a responder being defined as termination of a seizure within 90 seconds after IMP administration and 2) treatment success after IMP administration within the first 6 months (up to 10 maximum treated seizures) with a responder being someone who has termination of a seizure within 90 seconds after IMP administration AND no recurrence of seizure(s) from IMP administration to 2 hours after IMP administration AND has no initiation of seizure rescue treatment from 90 seconds to 2 hours after IMP administration. For the secondary safety objective, the endpoint is frequency of respiratory TEAEs.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All