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NCT07563881From ClinicalTrials.govRecruiting

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures

  • Focal Seizure
  • Epilepsy
  • Focal Epilepsy

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Rapport Therapeutics Inc.
Enrolment target
333
Started
5 June 2026
Main results due
July 2029
Study sites
13
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.

Study sites(13)

  • Amicis Research Center

    Palmdale, California, United States

    Recruiting

  • Panhandle Research and Medical Clinic, LLC

    Gulf Breeze, Florida, United States

    Recruiting

  • Emory Brain Health Center

    Atlanta, Georgia, United States

    Recruiting

  • Consultants in Epilepsy & Neurology, PLLC

    Boise, Idaho, United States

    Recruiting

  • Indiana University Health Fort Wayne Neurology

    Fort Wayne, Indiana, United States

    Recruiting

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, United States

    Recruiting

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, United States

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, United States

    Recruiting

  • Asheville Neurology Specialists

    Asheville, North Carolina, United States

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, United States

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Neurological Associates

    Richmond, Virginia, United States

    Recruiting

  • Seoul National University Hospital

    Seoul, Republic of Korea, South Korea

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07563881. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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