Clinical trial NCT03457129: Fycompa Titration Intervals and Effects on Retention Rate
Official title: Fycompa Titration Intervals and Effects on Retention Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Epilepsy
Epilepsy, partial onset
Epilepsy, generalized onset
Fycompa
perampanel
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
First posted: 2018-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

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).

Primary outcomes:
measure: The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].
timeFrame: Up to 52 weeks
measure: Seizures Frequency Per Week
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix
state: Arizona
Study officials:
affiliation: Banner University Medical Center
name: Norman C Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: