Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
NCT ID: NCT03208660
Last Updated: 2019-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2000 participants
OBSERVATIONAL
2017-04-07
2019-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Fycompa
Participants diagnosed with epilepsy and treated with Fycompa
Fycompa
Oral suspension
Interventions
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Fycompa
Oral suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Arizona Age Reversal & Neurology Clinic
Phoenix, Arizona, United States
Bronislava Shafran, MD, PC
Phoenix, Arizona, United States
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Arizona Neurological Institute
Sun City, Arizona, United States
The University of Arizona Department of Neurology
Tucson, Arizona, United States
Valley Children's Hospital
Madera, California, United States
UC Davis Medical Center
Sacramento, California, United States
Sutter Health
Sacramento, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Capernaum Medical Center
Lakeland, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Pediatric Neurology PA
Orlando, Florida, United States
Doctors hospital of Sarasota
Sarasota, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
University of South Florida
Tampa, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Consultants in Epilepsy & Neurology PLLC
Boise, Idaho, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health System
Detroit, Michigan, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
Hartsdale, New York, United States
Albert Einstein College of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Northwell Health
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Pennsylvania
Pittsburgh, Pennsylvania, United States
Le Bonheur Children's Hospital - PIN
Memphis, Tennessee, United States
Austin Epilepsy Center
Austin, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Auburn Neurological Institute
Auburn, Washington, United States
Northwest Neurology & Electrodiagnostic Center
Auburn, Washington, United States
Seattle Children's Hospital - PIN
Seattle, Washington, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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E2007-G000-506
Identifier Type: -
Identifier Source: org_study_id
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