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

Sponsor
Eisai Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03208660
Collaborator
(none)
2,000
Enrollment
44
Locations
23.2
Actual Duration (Months)
45.5
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Actual Study Start Date :
Apr 7, 2017
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Fycompa

Participants diagnosed with epilepsy and treated with Fycompa

Drug: Fycompa
Oral suspension
Other Names:
  • Perampanel

    		•

    Outcome Measures

    Primary Outcome Measures

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

    1. Number of participants with a 50% response rate [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline, Up to 24 months]

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

    12. Maximum dose of Fycompa [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 [Up to 24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants must have met all of the following criteria to be included in this study:

    1. Diagnosis of epilepsy

    2. Initiated treatment with Fycompa at any time after 01 Jan 2014

    3. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Age Reversal & Neurology Clinic Phoenix Arizona United States 85006
    2 Bronislava Shafran, MD, PC Phoenix Arizona United States 85006
    3 Banner - University Medical Center Phoenix Phoenix Arizona United States 85013
    4 Arizona Neurological Institute Sun City Arizona United States 85351
    5 The University of Arizona Department of Neurology Tucson Arizona United States 85724
    6 Valley Children's Hospital Madera California United States 93636
    7 UC Davis Medical Center Sacramento California United States 95814
    8 Sutter Health Sacramento California United States 95816
    9 Colorado Springs Neurological Associates Colorado Springs Colorado United States 80907
    10 Boca Raton Regional Hospital Boca Raton Florida United States 33486
    11 Capernaum Medical Center Lakeland Florida United States 33818
    12 Nicklaus Children's Hospital Miami Florida United States 33155
    13 Nemours Children's Hospital Orlando Florida United States 32801
    14 Pediatric Neurology PA Orlando Florida United States 32819
    15 Doctors hospital of Sarasota Sarasota Florida United States 34233
    16 Intercoastal Medical Group Sarasota Florida United States 34239
    17 University of South Florida Tampa Florida United States 33606
    18 Meridian Clinical Research Savannah Georgia United States 31406
    19 Consultants in Epilepsy & Neurology PLLC Boise Idaho United States 83702
    20 Carle Foundation Hospital Urbana Illinois United States 61801
    21 Fort Wayne Neurological Center Fort Wayne Indiana United States 46804
    22 Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland United States 20817
    23 Tufts Medical Center Boston Massachusetts United States 02111
    24 Wayne State University Detroit Michigan United States 48201
    25 Henry Ford Health System Detroit Michigan United States 48202
    26 Spectrum Health System Detroit Michigan United States 48202
    27 Spectrum Health Medical Group Grand Rapids Michigan United States 49503
    28 Minnesota Epilepsy Group Saint Paul Minnesota United States 55102
    29 Northeast Regional Epilepsy Group Hackensack New Jersey United States 07601
    30 Icahn School of Medicine at Mount Sinai Hartsdale New York United States 10530
    31 Albert Einstein College of Medicine New York New York United States 10003
    32 Columbia University Medical Center New York New York United States 10032
    33 Northwell Health New York New York United States 10075
    34 Duke University Medical Center Durham North Carolina United States 27710
    35 Oregon Health and Science University Portland Oregon United States 97239
    36 Albert Einstein Medical Center Philadelphia Pennsylvania United States 19141
    37 Pennsylvania Pittsburgh Pennsylvania United States 15212
    38 Le Bonheur Children's Hospital - PIN Memphis Tennessee United States 38105
    39 Austin Epilepsy Center Austin Texas United States 78758
    40 University of Texas Health Science Center at Houston Houston Texas United States 77030
    41 Auburn Neurological Institute Auburn Washington United States 98001
    42 Northwest Neurology & Electrodiagnostic Center Auburn Washington United States 98002
    43 Seattle Children's Hospital - PIN Seattle Washington United States 98105
    44 MultiCare Institute for Research and Innovation Tacoma Washington United States 98405-4048

    Sponsors and Collaborators

    • Eisai Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eisai Inc.
    ClinicalTrials.gov Identifier:
    NCT03208660
    Other Study ID Numbers:
    • E2007-G000-506
    First Posted:
    Jul 5, 2017
    Last Update Posted:
    Apr 11, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eisai Inc.
    seizure
    Fycompa
    Additional relevant MeSH terms:
    Epilepsy

    Study Results

    No Results Posted as of Apr 11, 2019