Fycompa Titration Intervals and Effects on Retention Rate
This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B).
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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).
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Fycompa 2 week titration intervals
|Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.||
Fycompa 3 week titration intervals
|Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.||
- University of Arizona
Study ContactStephanie L Marsh, BS, CCRC
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.