Fycompa Titration Intervals and Effects on Retention Rate
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Perampanel Oral Tablet
Intervention description: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; Epilepsy, partial onset; Epilepsy, generalized onset; Fycompa; perampanel

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must provide written informed consent signed by the subject or legal guardian prior to
             entering the study in accordance with ICH and GCP guidelines.

          2. Subject has a confirmed diagnosis of medically refractory epilepsy with or without
             secondary generalization for at least 12 months prior to visit 1.

          3. Subjects currently being treated with 1 to 3 antiepileptic medications with or without
             VNS (does not count as an AED).

          4. Subjects aged 18 to 75.

          5. Subject's requiring an additional epilepsy medication due to either uncontrolled
             seizures and/or lack of tolerability with current epilepsy medications.

          6. Can be safely treated, in the opinion of the investigator, with Fycompa.

          7. Able and agrees to follow the specified titration schedule.

          8. 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:

          1. Any history of non-epileptic or psychogenic seizures.

          2. Women who are currently pregnant, lactating or have plans to become pregnant in the
             immediate future.

          3. 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.

          4. Subjects with a suicidal attempt in the 12 months prior to Visit 1

          5. 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.

          6. Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.

          7. Any use of concomitant medication as listed in the drug insert, including medications
             known to be inducers of cytochrome P450 (CYP3A).