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New hope for tough seizures: Long-Term safety trial launches

NCT ID NCT07219407

Disease control Sponsor: Rapport Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the long-term safety of an experimental drug called RAP-219 in 30 adults whose focal seizures do not respond well to current treatments. Participants must have already completed a related earlier study. The goal is to see if RAP-219 remains safe and helps reduce seizure frequency over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy Focal epilepsy Focal onset seizure Focal seizure Refractory focal epilepsy Seizure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 770300, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Consultants in Epilepsy and Neurology, PLLC

    RECRUITING

    Boise, Idaho, 83702, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • NYU Langone Comprehensive Epilepsy Center

    RECRUITING

    New York, New York, 10016, United States

  • University of Pennsylvania - Department of Neurology

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.