Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Rapport Therapeutics Inc. · NCT07594119
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 312
- US sites recruiting
- 13
- Study start
- September 2026
- Record last updated
- October 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: RAP-219; RAP-219; Placebo
Conditions: Focal Seizure; Epilepsy; Focal Epilepsy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Age 18 - 75
- BMI 18-45 kg/m2
- Diagnosis of focal epilepsy for ≥24 months prior to Visit 1
- 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
- Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs
- Ability to keep accurate daily focal seizure records using an e-diary
Exclusion Criteria
- Known hypersensitivity or prior exposure to RAP-219.
- Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur
- Anticipated need for surgery during the study period
- Medical history of any of the following:
- generalized epilepsy
- focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type
- psychogenic nonepileptic seizure (PNES)
- status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).
- epilepsy surgery within 12 months prior to Visit 1 (Day -56).
- Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
Recruiting US locations
Clinic for Neurology
Huntsville, AL 35801
Pillar Clinical Research
Bentonville, AR 72712
Colorado Springs Neurological Associates
Colorado Springs, CO 80919
K2 Medical Research
Maitland, FL 32751
Serenity Research Center, LLC
Miami, FL 33176
Hawaii Pacific Neuroscience
Honolulu, HI 96817
Re:Cognition Health-Chicago
Chicago, IL 60611
University of Nebraska Medical Center
Omaha, NE 68105
Lenox Hill Hospital
New York, NY 10075
Velocity Clinical Research
Raleigh, NC 27607
Vanderbilt University Medical Center
Nashville, TN 37179
Baylor College of Medicine
Houston, TX 77030
University of Texas Health Science Center in Houston
Houston, TX 77030
Study contacts (from the official record)
- Rapport Medical · 857 323 9048 · RAP-219-FOS@rapportrx.com
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