Pharmacokinetics and Safety Study of Diazepam Buccal Film (DBF) in Pediatric Subjects With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label study to assess the pharmacokinetics of a single diazepam buccal film (DBF) dose
      in 3 age cohorts of pediatric patients with epilepsy (age 2-5 years, age 6-11 years, and age
      12-16 years). Subjects in the 6-11 years and 12-16 years age cohorts received a single DBF
      dose during the interictal period (Period A) and ictal/peri-ictal period (Period B) with at
      least 14 days washout between doses. Subjects in the age 2-5 years age cohort received a
      single DBF dose only during the ictal/peri-ictal period (Period B).
    

Detailed description: 
      This was a Phase 2 multicenter, open-label, two-way study conducted in male and female
      pediatric subjects (aged 2 to 16 years) with a clinical diagnosis of epilepsy who were
      scheduled to be admitted to an Epilepsy Monitoring Unit (EMU), a general clinical research
      center (GCRC), or similar facility for evaluation of seizures and who complied with all
      remaining protocol eligibility criteria. To ensure that 16 to 18 subjects would complete the
      study across 3 age ranges (2 to 5 years, 6 to 11 years, and 12 to 16 years), a minimum of 24
      subjects were to be enrolled (8 in each age cohort).

      Subjects in the 6 to 11 years and 12 to 16 years age cohorts received a single dose of DBF
      during the interictal period (Period A) and ictal/peri-ictal period (Period B) with at least
      14 days washout between doses. Subjects in the age 2 to 5 years age cohort received a single
      dose of DBF only during the ictal/peri-ictal period (Period B). DBF was provided in a range
      of doses from 5 to 17.5 mg. The appropriate dose of DBF was assigned on the basis of age and
      weight using an interactive web response system during check-in.

      Period A (interictal administration): Subjects were considered to be in an interictal state
      if an interval of at least 3 hours had elapsed since any clinically observable postictal
      signs or symptoms (from the last observed seizure) and the subject had been seizure-free over
      this period. Subjects on electroencephalogram (EEG) monitoring were to be considered to be in
      an interictal state if an interval of at least 3 hours had elapsed since there were any
      postictal electrical findings on EEG.

      Period B (ictal/peri-ictal administration): For the purpose of this study, the ictal state
      was defined as an ongoing clinically observable seizure or seizure activity as verified via
      EEG. The peri-ictal state was defined clinically as the subject's immediate postictal state
      following a generalized tonic-clonic (GTC) seizure or focal seizure with impaired awareness,
      and within 5 minutes following the last clonic jerk. For subjects on EEG monitoring, the
      peri-ictal state was to be defined as less than 5 minutes after cessation of seizure activity
      as verified via EEG.

      .
    

Intervention name(s): Diazepam Buccal Film
Intervention type(s): Drug
Intervention description(s): Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
Other intervention name(s): DBSF
Intervention MeSH terms: Diazepam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a multicenter study comprised of 2 treatment periods with a minimum 14 days between the 2 treatment periods.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interictal state; ictal/peri-ictal state