Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Perampanel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: epilepsy; partial-onset seizures; secondarily generalized seizures

Summary:

      This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of
      perampanel added to monotherapy for partial onset seizures with or without secondarily
      generalized seizures (total seizures).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of epilepsy with partial onset seizures with or without secondarily
             generalized seizures according to the International League Against Epilepsy's
             Classification of Epileptic Seizures (1981)

          -  Need an initial add-on therapy after failure to control seizures with the first or
             further monotherapy at the optimal dose and duration

          -  Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must
             have had greater than or equal to 2 partial onset seizures, and the interval between
             those seizures should be more than 24 hours prior to Visit 1 (Week 0).

          -  Are currently being treated with stable doses of monotherapy for 8 weeks prior to
             Visit 1 (Week 0) (Standard AEDs)

          -  If antidepressants or antianxiety drugs are used, participants must be receiving
             stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks
             prior to Visit 1 (Week 0)

        Exclusion Criteria:

          -  Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or
             breastfeeding

          -  Presence of previous history of Lennox-Gastaut syndrome

          -  Presence of nonmotor simple partial seizures only

          -  Presence of primary generalized epilepsies or seizures such as absences and/or
             myoclonic epilepsies

          -  A history of status epilepticus within 12 weeks before Visit 1 (Week 0)

          -  Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent
             affective disorder(s) with a history of attempted suicide within 1 year before Visit 1
             (Week 0)

          -  Presence of a progressive central nervous system (CNS) disease, including degenerative
             CNS diseases and progressive tumors

          -  Concomitant use of barbiturates (except for seizure control indication and
             premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure
             control indication) within 8 weeks prior to Visit 1 (Week 0)

          -  Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period
             considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week
             0)

          -  Participant who is participating in other intervention clinical trial