Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
- Focal Seizure
- Epilepsy
- Focal Epilepsy
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Rapport Therapeutics Inc.
- Enrolment target
- 333
- Started
- 5 June 2026
- Main results due
- July 2029
- Study sites
- 13
- Registry updated
- 25 September 2026
Can you take part?
- Ages 18 years to 75 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(13)
Amicis Research Center
Palmdale, California, United States
Recruiting
Panhandle Research and Medical Clinic, LLC
Gulf Breeze, Florida, United States
Recruiting
Emory Brain Health Center
Atlanta, Georgia, United States
Recruiting
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
Recruiting
Indiana University Health Fort Wayne Neurology
Fort Wayne, Indiana, United States
Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Recruiting
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Asheville Neurology Specialists
Asheville, North Carolina, United States
Recruiting
Cleveland Clinic
Cleveland, Ohio, United States
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Recruiting
Neurological Associates
Richmond, Virginia, United States
Recruiting
Seoul National University Hospital
Seoul, Republic of Korea, South Korea
Recruiting
Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07563881. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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