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Clinical Trials in the USA / NCT07219407
Recruiting Phase 2

A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures

NCT07219407 · tracked via the Priya Life Science USA tracker
Sponsor
Rapport Therapeutics Inc
Phase
Phase 2
Started
2025-12-15
Last updated
2026-01-23

Condition(s) studied

Focal EpilepsyEpilepsyRefractory Focal EpilepsySeizureFocal SeizureFocal Onset Seizure

Investigational drug(s) / intervention(s)

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.

Study summary

This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator. * 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: * Known of hypersensitivity to RAP-219 * 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

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events (TEAEs) — From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112

Trial sites (7)

FacilityCityRegionStatus
Consultants in Epilepsy and Neurology, PLLC Boise Idaho Recruiting
Mayo Clinic Rochester Minnesota Recruiting
NYU Langone Comprehensive Epilepsy Center New York New York Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
University of Pennsylvania - Department of Neurology Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting

More Rapport Therapeutics Inc. trials in the USA

Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1 Recruiting
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures Recruiting

Other trials for the same condition

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SIF001 in Healthy Subjects and in Epilepsy Patients Recruiting
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy Active, not recruiting
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy Active, not recruiting
Long-term Safety and Tolerability of BHV-7000 Enrolling by invitation
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07219407 on ClinicalTrials.gov ↗ ← All trials in the USA