Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures
Condition: Nonconvulsive Electrographic Seizures
MeSH terms: Seizures
Intervention: Brivaracetam intravenous solution; Brivaracetam oral tablets; Phenytoin intravenous solution; Phenytoin oral tablets
Intervention description: Active Substance: Brivaracetam
Pharmaceutical Form: Solution for infusion
Concentration: 10 mg/mL
Route of Administration: Intravenous bolus use; Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid)
Route of Administration: Oral use; Active Substance: Phenytoin
Pharmaceutical Form: Solution for infusion
Concentration: 50 mg/mL
Route of Administration: Intravenous use; Active Substance: Phenytoin
Pharmaceutical Form: Tablet
Concentration: Weight based
Route of Administration: Oral use
Intervention MeSH terms: Phenytoin; Brivaracetam; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Phenytoin; Nonconvulsive electrographic seizures

Summary:

      The primary objective of this study is to compare the efficacy of Brivaracetam and Phenytoin,
      both administered intravenously, in adult subjects experiencing nonconvulsive electrographic
      seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥16 years. Subjects under 18 years may only be included where legally
             permitted and ethically accepted

          -  Subjects in the neurological intensive care unit (NICU) (or equivalent closely
             monitored environment) having brain insult including traumatic brain injury and having
             nonconvulsive electrographic seizures (NCES) confirmed by electroencephalogram (EEG),
             lasting a minimum of 10 seconds but not >30 minutes (minimum of 1 seizure in the last
             6 hours) and treatment with an antiepileptic drug (AED) is required according to the
             physician's clinical judgment

          -  Subject is expected to be under cEEG monitoring with video surveillance in the Neuro
             ICU for at least 36 hours from the first administration of study drug

        Exclusion Criteria:

          -  Subject has history of severe adverse hematologic or cutaneous reaction to any drug

          -  Subject presenting with status epilepticus or nonconvulsive status epilepticus (NCSE)
             (ie, 1 continuous, convulsive or nonconvulsive, unremitting seizure lasting >30
             minutes during Visit 1)

          -  Subject has been diagnosed with anoxic brain injury

          -  Subject has a known history of status epilepticus during the 6 months preceding Visit
             1

          -  Subject is currently treated with Levetiracetam (LEV) or Phenytoin (PHT) or has been
             treated within the last 30 days before Visit 1 with LEV or PHT

          -  Subject is on felbamate with <18 months' exposure before Visit 1

          -  Subject has presence of any sign (clinical or imaging techniques) suggesting a rapidly
             progressing process such that the subject is not expected to survive >48 hours

          -  Subject has any clinical condition that would impair reliable participation in the
             study or necessitate the use of medications not allowed by the protocol