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Recruiting Phase 3

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

NCT07563881 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-06-05
Last updated
2026-11-06

Condition(s) studied

Focal SeizureEpilepsyFocal Epilepsy

Investigational drug(s) / intervention(s)

RAP-219 →RAP-219 →Placebo

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Median Percent Change in Seizure Frequency — End of double-blind treatment period (end of week 14) vs Baseline
    Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:

Trial sites (24)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Amicis Research Center Palmdale California Recruiting
Panhandle Research and Medical Clinic, LLC Gulf Breeze Florida Recruiting
Emory Brain Health Center Atlanta Georgia Recruiting
Consultants in Epilepsy & Neurology, PLLC Boise Idaho Recruiting
Southern Illinois University Neurology Clinic Springfield Illinois Recruiting
Indiana University Health Fort Wayne Neurology Fort Wayne Indiana Recruiting
Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland Recruiting
Northeast Regional Epilepsy Group Hackensack New Jersey Recruiting
Institute of Neurology and Neurosurgery at St. Barnabas Livingston New Jersey Recruiting
NYU Langone Health - Comprehensive Epilepsy Center New York New York Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Asheville Neurology Specialists Asheville North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
Neurological Associates Richmond Virginia Recruiting
The Alfred Hospital Melbourne Australia Recruiting
Prince of Wales Hospital Sydney Australia Recruiting
Dong-A University Hospital Busan Republic of Korea Recruiting
Korea University Anam Hospital Seoul Republic of Korea Recruiting
Seoul National University Hospital Seoul Republic of Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Korea University Guro Hopsital Seoul South Korea Recruiting
University Hospitals Plymouth NHS Trust Plymouth United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563881 on ClinicalTrials.gov ↗ ← All trials in the USA