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New epilepsy drug RAP-219 enters final testing phase

NCT ID NCT07563881

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 10 times

Summary

This study tests an experimental drug called RAP-219 in 333 adults with focal seizures (a type of epilepsy). The goal is to see if the drug safely reduces how often seizures happen compared to a placebo. Participants must be 18-75, have had focal epilepsy for at least 2 years, and take 1-3 other seizure medicines.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 333 people

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

Started

Jun 2026

Expected to finish

Sep 2029

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 75 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: 1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis 5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs 6. Ability to keep accurate daily focal seizure records using an e-diary Exclusion Criteria: 1. Known hypersensitivity or prior exposure to RAP-219. 2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur 3. Anticipated need for surgery during the study period 4. Medical history of any of the following: 1. generalized epilepsy 2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type 3. psychogenic nonepileptic seizure (PNES) 4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56). 5. epilepsy surgery within 12 months prior to Visit 1 (Day -56). 5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product

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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 seizure

How to take part

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

  1. The places running it

    11 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

  • Amicis Research Center

    RECRUITING

    Palmdale, California, 91324, United States

  • Asheville Neurology Specialists

    RECRUITING

    Asheville, North Carolina, 28806, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • Consultants in Epilepsy & Neurology, PLLC

    RECRUITING

    Boise, Idaho, 83702, United States

  • Emory Brain Health Center

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Indiana University Health Fort Wayne Neurology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Mid-Atlantic Epilepsy and Sleep Center

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • Neurological Associates

    RECRUITING

    Richmond, Virginia, 23236, United States

  • Northeast Regional Epilepsy Group

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Panhandle Research and Medical Clinic, LLC

    RECRUITING

    Gulf Breeze, Florida, 32561, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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