A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Condition: Partial-onset Seizures
MeSH terms: Seizures
Intervention: Perampanel; Placebo
Intervention description: Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.
Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day.; Core study: Week 0 to Week 18 Once daily placebo.
Extension study:
Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 940.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Partial-onset Seizures; partial seizures; seizure; epilepsy

Summary:

      The purpose of this study is to confirm the efficacy and safety of perampanel compared to
      placebo in patients with refractory partial-onset seizures
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female and greater than or equal to 12 years of age;

          2. Have a diagnosis of epilepsy with partial seizures with or without secondarily
             generalized seizures

          3. Participants with computed tomography (CT) or magnetic resonance imaging (MRI)
             diagnosis within the last 10 years (for adults) and 5 years (for adolescents) prior to
             visit 1 that ruled out progressive central nervous system (CNS) disorders, example,
             neurodegenerative disorders, brain tumors. For participants without existing CT or MRI
             results, CT or MRI was performed at or after Visit 1 but results evaluation was
             performed by Visit 2

          4. Participants who had been treated for at least 12 weeks but confirmed to be
             uncontrolled with more than one standard antiepileptic drug (AED) for 2 years before
             enrollment

          5. During the 6-week Prerandomization Phase participants must have had greater than or
             equal to 5 partial seizures per 6-week

          6. Are currently being treated with stable doses and administrations of 1, 2, or a
             maximum of 3 approved AEDs. Only 1 inducer AED (defined as carbamazepine, phenytoin or
             oxcarbazepine only) out of the maximum of 3 AEDs is allowed

        Exclusion Criteria

          1. Presence of nonmotor simple partial seizures only;

          2. Presence of primary generalized epilepsies or seizures, such as absences and/or
             myoclonic epilepsies;

          3. Presence or previous history of Lennox-Gastaut syndrome;

          4. A history of status epilepticus within 1 year prior to screening

          5. Seizure clusters where individual seizures cannot be counted

          6. A history of psychogenic seizures within 5 years prior to screening