Clinical trial NCT03208660: Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Official title: A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: seizure
Fycompa
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)
timeFrame: 3, 6, 12, 18, and 24 months
Secondary outcomes:
measure: Number of participants with a 50% response rate
timeFrame: up to 24 months
measure: Number of participants with a 75% response rate
timeFrame: up to 24 months
measure: Number of participants with a 100% response rate
timeFrame: up to 24 months
measure: Categorized percent reduction in seizure frequency from baseline
timeFrame: Baseline, up to 24 months
measure: Median percent change in seizure frequency from baseline
timeFrame: Baseline, up to 24 months
measure: Percentage of participants who had no change or a worsening of seizures from baseline
timeFrame: Baseline, up to 24 months
measure: Total provider health care visits before, during, and after final dose of Fycompa
timeFrame: 6 months before initiation of Fycompa to 6 months after last dose of Fycompa
measure: Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa
timeFrame: Up to 24 months
measure: Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa
timeFrame: Up to 24 months
measure: Mean change in body weight from baseline
timeFrame: Baseline, Up to 24 months
measure: Mean change in height of pediatric participants from baseline
timeFrame: Baseline, Up to 24 months
measure: Maximum dose of Fycompa
timeFrame: Up to 24 months
measure: Average dose of Fycompa
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Age Reversal & Neurology Clinic
state: Arizona
city: Phoenix
country: United States
facility: Bronislava Shafran, MD, PC
state: Arizona
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Sun City
country: United States
facility: Arizona Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Department of Neurology
state: Arizona
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Lakeland
country: United States
facility: Capernaum Medical Center
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology PA
state: Florida
city: Sarasota
country: United States
facility: Doctors hospital of Sarasota
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Boise
country: United States
facility: Consultants in Epilepsy & Neurology PLLC
state: Idaho
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Spectrum Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Medical Group
state: Michigan
city: Saint Paul
country: United States
facility: Minnesota Epilepsy Group
state: Minnesota
city: Hackensack
country: United States
facility: Northeast Regional Epilepsy Group
state: New Jersey
city: Hartsdale
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital - PIN
state: Tennessee
city: Austin
country: United States
facility: Austin Epilepsy Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Auburn
country: United States
facility: Auburn Neurological Institute
state: Washington
city: Auburn
country: United States
facility: Northwest Neurology & Electrodiagnostic Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital - PIN
state: Washington
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.