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EpilepsyNCT03208660

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

An observational study of Epilepsy, run by Eisai Inc. at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Epilepsy
What is being tested?
Fycompa
Type of treatment
Pill or oral medicine
How many people
2,000 participants
Where
44 sitesUnited States
Study dates
7 Apr 2017to 15 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Data will be obtained by reviewing the medical records of the participants with a diagnosis of epilepsy and treated with Fycompa on clinician's recommendation at up to approximately 40 epilepsy centers.

Who may be able to join

  • 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).

Who cannot join

  • Not applicable

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Auburn Neurological Institute

    Auburn, Washington, 98001

  • Northwest Neurology & Electrodiagnostic Center

    Auburn, Washington, 98002

  • Austin Epilepsy Center

    Austin, Texas, 78758

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Consultants in Epilepsy & Neurology PLLC

    Boise, Idaho, 83702

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Spectrum Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Spectrum Health Medical Group

    Grand Rapids, Michigan, 49503

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

  • Icahn School of Medicine at Mount Sinai

    Hartsdale, New York, 10530

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Capernaum Medical Center

    Lakeland, Florida, 33818

  • Valley Children's Hospital

    Madera, California, 93636

  • Le Bonheur Children's Hospital - PIN

    Memphis, Tennessee, 38105

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Albert Einstein College of Medicine

    New York, New York, 10003

  • Columbia University Medical Center

    New York, New York, 10032

  • Northwell Health

    New York, New York, 10075

  • Nemours Children's Hospital

    Orlando, Florida, 32801

  • Pediatric Neurology PA

    Orlando, Florida, 32819

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Arizona Age Reversal & Neurology Clinic

    Phoenix, Arizona, 85006

  • Bronislava Shafran, MD, PC

    Phoenix, Arizona, 85006

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85013

  • Pennsylvania

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UC Davis Medical Center

    Sacramento, California, 95814

  • Sutter Health

    Sacramento, California, 95816

  • Minnesota Epilepsy Group

    Saint Paul, Minnesota, 55102

  • Doctors hospital of Sarasota

    Sarasota, Florida, 34233

  • Intercoastal Medical Group

    Sarasota, Florida, 34239

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Seattle Children's Hospital - PIN

    Seattle, Washington, 98105

  • Arizona Neurological Institute

    Sun City, Arizona, 85351

  • MultiCare Institute for Research and Innovation

    Tacoma, Washington, 98405-4048

  • University of South Florida

    Tampa, Florida, 33606

  • The University of Arizona Department of Neurology

    Tucson, Arizona, 85724

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: A Retrospective Multicenter 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.

Conditions
Epilepsy
Being tested
Fycompa
Keywords
seizure, Fycompa
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FycompaDrug

    Also called Perampanel

    Oral suspension

Study groups in NCT03208660
Study groupRoleWhat they receive
FycompaParticipants diagnosed with epilepsy and treated with Fycompa
Receives: Drug: Fycompa

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 3, 6, 12, 18, and 24 months

Secondary outcomes (13)

  1. Number of participants with a 50% response rate

    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.

    Measured: up to 24 months

  2. Number of participants with a 75% response rate

    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.

    Measured: up to 24 months

  3. Number of participants with a 100% response rate

    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.

    Measured: up to 24 months

  4. Categorized percent reduction in seizure frequency from baseline

    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).

    Measured: Baseline, up to 24 months

  5. Median percent change in seizure frequency from baseline

    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).

    Measured: Baseline, up to 24 months

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

    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).

    Measured: Baseline, up to 24 months

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

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

    Measured: 6 months before initiation of Fycompa to 6 months after last dose of Fycompa

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

    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.

    Measured: Up to 24 months

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

    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.

    Measured: Up to 24 months

  10. Mean change in body weight from baseline

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

    Measured: Baseline, Up to 24 months

  11. Mean change in height of pediatric participants from baseline

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

    Measured: Baseline, Up to 24 months

  12. Maximum dose of Fycompa

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

    Measured: Up to 24 months

  13. Average dose of Fycompa

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

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start7 Apr 2017
  3. Primary completion15 Mar 2019
  4. Study completion15 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03208660
Sponsor's protocol ID
E2007-G000-506
Status last verified
Mar 2019
First submitted
3 Jul 2017
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Segal E, Wheless J, Moretz K, Penovich P, Patten A, Malhotra M. Perampanel in real-world clinical care of adolescent and adult patients with epilepsy: Results from the retrospective Phase IV PROVE Study. Seizure. 2022 May;98:87-94. doi: 10.1016/j.seizure.2022.02.011. Epub 2022 Feb 26.

    PubMed 35453064

  • Segal E, Moretz K, Wheless J, Penovich P, Lancman M, Patten A, Malhotra M. PROVE-Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients. J Child Neurol. 2022 Mar;37(4):256-267. doi: 10.1177/08830738211047665. Epub 2022 Jan 7.

    PubMed 34994582

  • Wechsler RT, Wheless J, Zafar M, Huesmann GR, Lancman M, Segal E, Chez M, Aboumatar S, Patten A, Salah A, Malhotra M. PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy. Epilepsia Open. 2022 Jun;7(2):293-305. doi: 10.1002/epi4.12575. Epub 2022 Mar 20.

    PubMed 34942053

  • Wheless J, Wechsler RT, Lancman M, Aboumatar S, Patten A, Malhotra M. Perampanel in real-world clinical care of patients with epilepsy: Interim analysis of a phase IV study. Epilepsia Open. 2020 Dec 19;6(1):79-89. doi: 10.1002/epi4.12445. eCollection 2021 Mar.

    PubMed 33681651

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by Eisai Inc. at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208660, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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