A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
NCT ID: NCT07219407
Last Updated: 2026-01-23
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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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-12-15
2028-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RAP-219
RAP-219
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
Interventions
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RAP-219
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of refractory focal epilepsy
* Stable RNS(c) system settings
* A demonstrated history of compliance with RNS(c) system data interrogation and upload
* Good overall health other than focal epilepsy, per Investigator.
* BMI ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2
* Willing and able to adhere to all aspects of the protocol.
Exclusion Criteria
* Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
* Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
18 Years
70 Years
ALL
No
Sponsors
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Rapport Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Imran Quraishi, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, United States
Mayo Clinic
Rochester, Minnesota, United States
NYU Langone Comprehensive Epilepsy Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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RAP-219-FOS-901
Identifier Type: -
Identifier Source: org_study_id
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