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Long-term Study of RAP-219 for Focal Onset Seizures

This study is looking at the long-term safety and how well an investigational drug called RAP-219 works for adults with refractory focal epilepsy (seizures that start in one part of the brain and haven't responded well to other treatments). You would take RAP-219 capsules and tablets daily, with the dose increasing over time. The main goal is to track any side effects you might experience. To join, you must have already completed a related study (RAP-219-FOS-201) and have refractory focal epilepsy. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an open-label study, meaning everyone knows what treatment is being given. It plans to enroll 30 adult participants.
What's involved
You would take RAP-219 daily, starting with a 0.125 mg capsule for 3 days, then a 0.25 mg tablet for 28 days, and finally a 0.75 mg tablet for the rest of the treatment period.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of RAP-219 treatment through 8 weeks after your last dose, up to Week 112.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219407

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Rapport Therapeutics Inc.
~30 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:RAP-219

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs)
Measured over From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112

Conditions

Focal Epilepsy
Epilepsy
Refractory Focal Epilepsy
Seizure
Focal Seizure
Focal Onset Seizure

Explore related trials

Partial Epilepsy

Where it's being run

7 sites across 7 states
Idaho1
Minnesota1
New York1
Ohio1
Pennsylvania1
Tennessee1
Texas1

Study leadership

  • Imran Quraishi, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Daniela Moreno
[email protected]
(857) 323-9048
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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