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Fycompa Titration Intervals and Effects on Retention Rate

Primary Purpose

Epilepsy

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Perampanel Oral Tablet

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Epilepsy, partial onset, Epilepsy, generalized onset, Fycompa, perampanel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Banner University Medical Center Phoenix

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fycompa 2 week titration intervals

Fycompa 3 week titration intervals

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].

Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].

Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.

Seizures Frequency Per Week

The average of seizures per week will be calculated starting at initial titration through final maintenance [Efficacy]."

Full Information

NCT ID

NCT03457129

First Posted

November 3, 2017

Last Updated

July 24, 2023

Sponsor

University of Arizona

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03457129

Brief Title

Fycompa Titration Intervals and Effects on Retention Rate

Official Title

Fycompa Titration Intervals and Effects on Retention Rate

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 18, 2018 (Actual)

Primary Completion Date

February 24, 2021 (Actual)

Study Completion Date

December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

Collaborators

Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy

Keywords

Epilepsy, Epilepsy, partial onset, Epilepsy, generalized onset, Fycompa, perampanel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fycompa 2 week titration intervals

Arm Type

Active Comparator

Arm Description

Arm Title

Fycompa 3 week titration intervals

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Perampanel Oral Tablet

Other Intervention Name(s)

Fycompa

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.

Primary Outcome Measure Information:

Title

The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].

Description

Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.

Time Frame

Up to 52 weeks

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].

Description

Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.

Time Frame

Up to 52 weeks

Title

Seizures Frequency Per Week

Description

The average of seizures per week will be calculated starting at initial titration through final maintenance [Efficacy]."

Time Frame

Up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman C Wang, MD

Organizational Affiliation

Banner University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Banner University Medical Center Phoenix

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

At this time, there is no plan to share individual participant data with other researchers.

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Fycompa Titration Intervals and Effects on Retention Rate

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