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

RecruitingPhase 3

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

Who can join

Ages 18 to 75 · All sexes

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

About the study

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.

What is being tested

Sponsor: Rapport Therapeutics Inc. · Participants: 312 · Started: 2026-09

Contact the study team

Official record on ClinicalTrials.gov — NCT07594119

Locations in the U.S.

AlabamaClinic for Neurology, Huntsville
ArkansasPillar Clinical Research, Bentonville
ColoradoColorado Springs Neurological Associates, Colorado Springs
FloridaK2 Medical Research, Maitland
Serenity Research Center, LLC, Miami
IllinoisRe:Cognition Health-Chicago, Chicago
New YorkLenox Hill Hospital, New York
North CarolinaVelocity Clinical Research, Raleigh
TennesseeVanderbilt University Medical Center, Nashville
TexasBaylor College of Medicine, Houston
University of Texas Health Science Center in Houston, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.