Phase
Condition
Epilepsy
Treatment
RAP-219
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Medically refractory focal epilepsy with an implanted responsive neurostimulatordevice placed correctly in a seizure onset zone that meet several device-relatedcriteria and demonstrated history of compliance with interrogation of the RNS deviceand upload of data
If currently treated with antiseizure medications, up to a maximum of 4 concomitantmediations are allowed
At least 1 clinical seizure during the 8-week retrospective eligibility period
Participants in otherwise good health as determined by the investigator
Willing and able to adhere to all aspects of the protocol
A demonstrated history of compliance with interrogation of the RNS device and uploadof data before screening
Exclusion
Exclusion Criteria:
Participants with generalized onset seizures in the past 10 years
History of status epilepticus while on antiseizure medications within 2 years ofscreening
Individuals of reproductive potential who do not agree to simultaneously use twoeffective birth-control methods
Participants who have had epilepsy surgery within the last 12 months beforescreening
Study Design
Study Description
Connect with a study center
Yale University
New Haven, Connecticut 06519
United StatesSite Not Available
Emory Brain Health Center
Atlanta, Georgia 30329
United StatesSite Not Available
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho 83702
United StatesSite Not Available
IU Health Neuroscience Center, Goodman Hall
Indianapolis, Indiana 46202
United StatesSite Not Available
The University of Kansas Medical Center Epilepsy Clinic
Kansas City, Kansas 66160
United StatesSite Not Available
Corewell Health Research Institute
Grand Rapids, Michigan 49503
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
University of Texas Health Science Center, Houston Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
NYU Langone Comprehensive Epilepsy Center
New York, New York 10016
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 770300
United StatesSite Not Available
University of Texas Health Science Center, Houston
Houston, Texas 77030
United StatesSite Not Available
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