Fycompa Titration Intervals and Effects on Retention Rate

NCT03457129 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Fycompa Titration IIS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Epilepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 52 weeks

Secondary Outcomes (2)

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

  Up to 52 weeks

• Seizures Frequency Per Week

  Up to 52 weeks

Study Arms (2)

Fycompa 2 week titration intervals

ACTIVE COMPARATOR

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.

Drug: Perampanel Oral Tablet

Fycompa 3 week titration intervals

EXPERIMENTAL

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.

Drug: Perampanel Oral Tablet

Interventions

Perampanel Oral Tablet 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.

Also known as: Fycompa

Fycompa 2 week titration intervals; Fycompa 3 week titration intervals

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arizona: lead
• Eisai Inc.: collaborator

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Stephanie Marsh, MPH, CCRC
• Organization: University of Arizona, College of Medicine Phoenix

slmarsh@arizona.edu

602-255-7552

Study Officials

• Norman C Wang, MD

  Banner University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: March 7, 2018
• Study Start: April 18, 2018
• Primary Completion: February 24, 2021
• Study Completion: December 15, 2021
• Last Updated: August 15, 2023
• Results First Posted: December 8, 2021

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)