Study of Diazepam Buccal Film Administered in the Interictal and in the Ictal-Periictal States to Adults With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 open-label, two-way study was conducted in adult subjects with epilepsy who were
      on stable regimens of anti-epileptic drugs (AEDs) and who were admitted to an Epilepsy
      Monitoring Unit (EMU), General Clinical Research Center (GCRC), or similar facility for
      evaluation of their seizures. All subjects received a single DBF 12.5 mg dose during the
      Interictal State and a single DBF 12.5 mg dose during the Ictal/peri-ictal state with at
      least 14 days washout between the 2 doses.
    

Detailed description: 
      This was a Phase 2 multicenter, open-label, two-way study conducted in adult subjects to
      assess the bioavailability, pharmacokinetics, and safety of DBF during the Interictal Period
      and during the Ictal/peri-ictal Period, with a minimum of 14 days of washout between periods.
      Subjects had a clinical diagnosis of epilepsy (with generalized tonic-clonic seizures or
      focal seizures with impaired awareness) who were on stable regimens of anti-epileptic drugs
      and were scheduled for admission to an EMU, GCRC, or similar facility for evaluation.

      All subjects were to receive a single 12.5-mg dose of study drug, without regard to meals,
      during both Interictal Period and Ictal/peri-ictal Period. The treatment was identical for
      both periods. Treatment sequence was not randomized. The interictal period and
      ictal/peri-ictal could occur in either order as determined by seizure occurrence.

      Interictal Period: 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) video 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.

      Ictal/peri-ictal Period: For the purposes of this study, the ictal state was defined as an
      ongoing clinically observable seizure or seizure activity as verified via EEG. The periictal
      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 video monitoring, the periictal
      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 12.5 mg
Intervention type(s): Drug
Intervention description(s): All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods
Other intervention name(s): DBF 12.5mg
Intervention MeSH terms: Diazepam
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a multicenter, open-label study comprised of 2 treatment periods with a minimum 14 days washout between the 2 treatment periods.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interictal; Ictal/peri-ictal