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Recruiting Phase 3

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

NCT07594119 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-01
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 medium dose tablets administered orally daily

RAP-219: RAP-219 low dose tablets administered orally daily

Placebo: Matching placebo tablets administered orally

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 (14)

FacilityCityRegionStatus
Clinic for Neurology Huntsville Alabama Recruiting
Pillar Clinical Research Bentonville Arkansas Recruiting
Colorado Springs Neurological Associates Colorado Springs Colorado Recruiting
K2 Medical Research Maitland Florida Recruiting
Serenity Research Center, LLC Miami Florida Recruiting
Hawaii Pacific Neuroscience Honolulu Hawaii Recruiting
Re:Cognition Health-Chicago Chicago Illinois Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Lenox Hill Hospital New York New York Recruiting
Velocity Clinical Research Raleigh North Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting
University of Texas Health Science Center in Houston Houston Texas Recruiting
Eastern Health Clinical School, Monach University Box Hill Melbourne Australia 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 NCT07594119 on ClinicalTrials.gov ↗ ← All trials in the USA