Fycompa Titration Intervals and Effects on Retention Rate

NCT ID: NCT03457129

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-18
• Study Completion Date: 2021-12-15

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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Perampanel Oral Tablet

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Perampanel Oral Tablet

Intervention Type: DRUG

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.

Interventions

Perampanel Oral Tablet

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.

Intervention Type: DRUG

Other Intervention Names

Fycompa

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Marsh

Clinical Research Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman C Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Banner University Medical Center

Locations

Banner University Medical Center Phoenix

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Fycompa Titration IIS

Identifier Type: -

Identifier Source: org_study_id