Not Yet RecruitingPhase 3

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

333 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Median Percent Change in Seizure Frequency

Timeframe: End of double-blind treatment period (end of week 14) vs Baseline

Trial details

NCT IDNCT07563881

SponsorRapport Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07

Contact for this trial

Rapport Medical

857 323 9048 RAP-219-FOS@rapportrx.com

View on ClinicalTrials.gov More Focal Seizure trials