Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Rapport Therapeutics Inc.
312 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria10
- 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
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Interventions
RAP-219 medium dose tablets administered orally daily
RAP-219 low dose tablets administered orally daily
Matching placebo tablets administered orally
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07594119