Status:
COMPLETED
Fycompa Titration Intervals and Effects on Retention Rate
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Eisai Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 consis...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03457129
Start Date
April 18 2018
End Date
December 15 2021
Last Update
August 15 2023
Active Locations (1)
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1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006