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

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

NCT07563881

Run by

Rapport Therapeutics Inc.

People needed

333

Starts

2026-06-05

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

• Amicis Research Center — Palmdale, California, United States (enrolling)
• Panhandle Research and Medical Clinic, LLC — Gulf Breeze, Florida, United States (enrolling)
• Indiana University Health Fort Wayne Neurology — Fort Wayne, Indiana, United States (enrolling)
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States (enrolling)
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• Neurological Associates — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.