Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: perampanel
Intervention description: Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1218.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Partial onset seizures

Summary:

      The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12
      mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to
      evaluate the maintenance of effect of perampanel for the control of refractory partial
      seizures.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant who met the following criteria were enrolled in this study:

          1. Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and
             complied with the inclusion and exclusion criteria for that study (excluding criteria
             that are related to seizure occurrences).

          2. Provided written informed consent signed by participant or legal guardian prior to
             entering the study or undergoing any study procedures (If the written informed consent
             was provided by the legal guardian because the participant was unable to do so, a
             written or verbal assent from the participant was obtained).

          3. Who was considered reliable and willing to be available for the study period and
             record seizures and report adverse events them self or have a caregiver who can record
             and report the events for them.

          4. Females who were either of non-childbearing potential (defined as having undergone
             surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or
             of childbearing potential. Females of childbearing potential were enrolled only if
             they agreed to be abstinent or continue using at least 1 medically acceptable method
             of contraception (eg, a double-barrier method [eg, condom + spermicide, condom +
             diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study
             period and for 2 months after the last dose of study drug. Women using hormonal
             contraceptives were required to use an additional approved method of contraception (as
             described previously) continuously throughout the entire study period and for 2 months
             after the last dose of study drug. (It was not required for male subjects to use
             contraceptive measures based on preclinical toxicology data).

          5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved
             anti-epileptic drugs.

        Exclusion Criteria:

        Participants who met the following criteria were excluded from the study:

        1. Those who, for any reason, discontinued early from the preceding double-blind study.