Fycompa Titration Intervals and Effects on Retention Rate

A total of 60 subjects with a confirmed diagnosis of either partial onset or primary generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day. Subjects in this group will be designated Group A. The remaining 30 subjects will also begin perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6 mg/day and will be designated Group B.

Inclusion criteria

• Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
• Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
• Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
• Subjects aged 18 to 75.
• Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
• Can be safely treated, in the opinion of the investigator, with Fycompa.
• Able and agrees to follow the specified titration schedule.
• Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion criteria

• Any history of non-epileptic or psychogenic seizures.
• Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
• Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
• Subjects with a suicidal attempt in the 12 months prior to Visit 1
• Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
• Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
• Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).