- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03457129
Fycompa Titration Intervals and Effects on Retention Rate
July 24, 2023 updated by: Stephanie Marsh, University of Arizona
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).
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner University Medical Center Phoenix
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
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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.
Other Names:
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Experimental: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
Time Frame: Up to 52 weeks
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Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.
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Up to 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].
Time Frame: Up to 52 weeks
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Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.
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Up to 52 weeks
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Seizures Frequency Per Week
Time Frame: Up to 52 weeks
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The average of seizures per week will be calculated starting at initial titration through final maintenance [Efficacy]."
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Up to 52 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Norman C Wang, MD, Banner University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2018
Primary Completion (Actual)
February 24, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
November 3, 2017
First Submitted That Met QC Criteria
March 5, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fycompa Titration IIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At this time, there is no plan to share individual participant data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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