Skip to main content
OpenTrials
Completed

NCT Number: NCT03208660

Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Age Reversal & Neurology Clinic, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have met all of the following criteria to be included in this study:
  • Diagnosis of epilepsy
  • Initiated treatment with Fycompa at any time after 01 Jan 2014
  • Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board [IRB] or Independent Ethics Committee [IEC], or by regulatory authorities).

Exclusion criteria

  • Not applicable

Treatment and study plan

Fycompa

Drug

Oral suspension

Other names: Perampanel

Primary outcomes

  1. Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)

    Time frame: 3, 6, 12, 18, and 24 months

    Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.

Secondary outcomes

  1. Number of participants with a 50% response rate

    Time frame: up to 24 months

    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.

  2. Number of participants with a 75% response rate

    Time frame: up to 24 months

    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.

  3. Number of participants with a 100% response rate

    Time frame: up to 24 months

    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.

  4. Categorized percent reduction in seizure frequency from baseline

    Time frame: Baseline, up to 24 months

    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).

  5. Median percent change in seizure frequency from baseline

    Time frame: Baseline, up to 24 months

    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).

  6. Percentage of participants who had no change or a worsening of seizures from baseline

    Time frame: Baseline, up to 24 months

    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).

  7. Total provider health care visits before, during, and after final dose of Fycompa

    Time frame: 6 months before initiation of Fycompa to 6 months after last dose of Fycompa

    Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable.

  8. Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa

    Time frame: Up to 24 months

    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  9. Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa

    Time frame: Up to 24 months

    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.

  10. Mean change in body weight from baseline

    Time frame: Baseline, Up to 24 months

    Change from baseline is calculated as the post-baseline value minus the baseline value.

  11. Mean change in height of pediatric participants from baseline

    Time frame: Baseline, Up to 24 months

    Change from baseline is calculated as the post-baseline value minus the baseline value.

  12. Maximum dose of Fycompa

    Time frame: Up to 24 months

    The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.

  13. Average dose of Fycompa

    Time frame: Up to 24 months

    The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2017
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.