Recruiting
Phase 3

RAP-219

Sponsor:

Rapport Therapeutics Inc.

Code:

NCT07563881

Conditions

Focal Seizure

Epilepsy

Focal Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RAP-219

RAP-219

Placebo

Study Details

Brief summary:

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.

Conditions

Focal Seizure

Epilepsy

Focal Epilepsy

Study ID

NCT07563881

Start date

Jun 5, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

333 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Arm- High Dose

RAP-219 daily tablets administered orally

experimental: Active Arm- Medium Dose

RAP-219 daily tablets administered orally

placebo comparator: Placebo

Inert comparator matching the active treatment

Interventions

RAP-219

RAP-219 high dose tablets administered orally daily

RAP-219

RAP-219 medium dose tablets administered orally daily

Placebo

Matching placebo tablets administered orally daily

Primary outcome measure

  • Median Percent Change in Seizure Frequency [ Time Frame: End of double-blind treatment period (end of week 14) vs Baseline ]

Central Contacts and Locations

Central contacts

Locations

Amicis Research Center

Recruiting

Palmdale, California, United States, 91324

Panhandle Research and Medical Clinic, LLC

Recruiting

Gulf Breeze, Florida, United States, 32561

Emory Brain Health Center

Recruiting

Atlanta, Georgia, United States, 30329

Consultants in Epilepsy & Neurology, PLLC

Recruiting

Boise, Idaho, United States, 83702

Indiana University Health Fort Wayne Neurology

Recruiting

Fort Wayne, Indiana, United States, 46804

Mid-Atlantic Epilepsy and Sleep Center

Recruiting

Bethesda, Maryland, United States, 20817

Northeast Regional Epilepsy Group

Recruiting

Hackensack, New Jersey, United States, 07601

Asheville Neurology Specialists

Recruiting

Asheville, North Carolina, United States, 28806

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44109

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Neurological Associates

Recruiting

Richmond, Virginia, United States, 23236

More Information

Sponsor

Rapport Therapeutics Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Focal Preserved Consciousness
  • Focal Impaired Consciousness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rapport Therapeutics Inc. on 2026-09-01.