A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
Condition: Seizure Disorder Generalized Tonic Clonic
MeSH terms: Seizures; Epilepsy
Intervention: Perampanel; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Central Nervous System

Summary:

      This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of
      perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and
      adults maintained on one to two stable antiepileptic drugs (AED).
    

Eligibility criteria:

        Inclusion:

          1. Clinical diagnosis of PGTC seizures (with or without other subtypes of primary
             generalized seizures) and experiencing greater than or equal to 3 PGTC seizures during
             the 8-week period prior to randomization

          2. Have had a routine electroencephalogram (EEG) prior to or during the Baseline Period
             with electroencephalographic features consistent with primary generalized epilepsy;
             other concomitant anomaly should be explained by adequate past medical history

          3. On a fixed dose of one to a maximum of three concomitant antiepileptic drugs (AEDs)
             for a minimum of 30 days prior to Baseline; only one inducer AED (i.e., carbamazepine,
             oxcarbazepine, or phenytoin) out of the maximum of two AEDs will be allowed

          4. A vagal nerve stimulator (VNS) will be allowed, but it must have been implanted
             greater than or equal to 5 months prior to Baseline (stimulator parameters cannot be
             changed for 30 days prior to Baseline and for the duration of the study).

          5. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the
             last 10 years (for adults) and 5 years (for adolescents) that ruled out a progressive
             cause of epilepsy

          6. A ketogenic diet will be allowed as long as the participant has been on this diet for
             5 weeks prior to randomization

        Exclusion:

          1. A history of status epilepticus that required hospitalization within 12 months prior
             to Baseline

          2. Seizure clusters where individual seizures cannot be counted

          3. A history of psychogenic seizures

          4. Concomitant diagnosis of Partial Onset Seizures (POS)

          5. Progressive neurological disease

          6. Clinical diagnosis of Lennox-Gastaut syndrome

          7. If felbamate is used as a concomitant AED, participants must be on felbamate for at
             least 2 years, with a stable dose for 60 days prior to Baseline. They must not have a
             history of white blood cell (WBC) count below less than or equal to 2500/microL (2.50
             1E+09/L), platelets less than 100,000/microL, liver function tests (LFTs) greater than
             3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow
             dysfunction while receiving felbamate.

          8. Concomitant use of vigabatrin: Participants who took vigabatrin in the past must be
             discontinued for approximately 5 months prior to Baseline, and must have documentation
             showing no evidence of a vigabatrin-associated clinically significant abnormality in
             an automated visual perimetry test

          9. Concomitant use of barbiturates (except for seizure control indication) within 30 days
             prior to Baseline

         10. Use of intermittent rescue benzodiazepines (i.e., one to two doses over a 24-hour
             period considered one-time rescue) two or more times within the 30 days prior to
             Baseline