Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
1 other identifier
observational
2,000
1 country
44
Brief Summary
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedApril 11, 2019
March 1, 2019
1.9 years
July 3, 2017
April 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
3, 6, 12, 18, and 24 months
Secondary Outcomes (13)
Number of participants with a 50% response rate
up to 24 months
Number of participants with a 75% response rate
up to 24 months
Number of participants with a 100% response rate
up to 24 months
Categorized percent reduction in seizure frequency from baseline
Baseline, up to 24 months
Median percent change in seizure frequency from baseline
Baseline, up to 24 months
- +8 more secondary outcomes
Study Arms (1)
Fycompa
Participants diagnosed with epilepsy and treated with Fycompa
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (44)
Arizona Age Reversal & Neurology Clinic
Phoenix, Arizona, 85006, United States
Bronislava Shafran, MD, PC
Phoenix, Arizona, 85006, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85013, United States
Arizona Neurological Institute
Sun City, Arizona, 85351, United States
The University of Arizona Department of Neurology
Tucson, Arizona, 85724, United States
Valley Children's Hospital
Madera, California, 93636, United States
UC Davis Medical Center
Sacramento, California, 95814, United States
Sutter Health
Sacramento, California, 95816, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Capernaum Medical Center
Lakeland, Florida, 33818, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Nemours Children's Hospital
Orlando, Florida, 32801, United States
Pediatric Neurology PA
Orlando, Florida, 32819, United States
Doctors hospital of Sarasota
Sarasota, Florida, 34233, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33606, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Consultants in Epilepsy & Neurology PLLC
Boise, Idaho, 83702, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Spectrum Health System
Detroit, Michigan, 48202, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55102, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601, United States
Icahn School of Medicine at Mount Sinai
Hartsdale, New York, 10530, United States
Albert Einstein College of Medicine
New York, New York, 10003, United States
Columbia University Medical Center
New York, New York, 10032, United States
Northwell Health
New York, New York, 10075, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Pennsylvania
Pittsburgh, Pennsylvania, 15212, United States
Le Bonheur Children's Hospital - PIN
Memphis, Tennessee, 38105, United States
Austin Epilepsy Center
Austin, Texas, 78758, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Auburn Neurological Institute
Auburn, Washington, 98001, United States
Northwest Neurology & Electrodiagnostic Center
Auburn, Washington, 98002, United States
Seattle Children's Hospital - PIN
Seattle, Washington, 98105, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, 98405-4048, United States
Related Publications (4)
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.
PMID: 35453064DERIVEDSegal 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.
PMID: 34994582DERIVEDWechsler 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.
PMID: 34942053DERIVEDWheless 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.
PMID: 33681651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2017
First Posted
July 5, 2017
Study Start
April 7, 2017
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
April 11, 2019
Record last verified: 2019-03