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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Focal Seizure, Epilepsy, Focal Epilepsy

In brief

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.

Key facts

Study ID

NCT07594119

Run by

Rapport Therapeutics Inc.

People needed

312

Starts

2026-08-01

Expected to finish

2029-09-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pillar Clinical Research — Bentonville, Arkansas, United States (enrolling)
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States (enrolling)
• K2 Medical Research — Maitland, Florida, United States (enrolling)
• Serenity Research Center, LLC — Miami, Florida, United States (enrolling)
• Velocity Clinical Research — Raleigh, North Carolina, United States (enrolling)
• University of Texas Health Science Center in Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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