RAP-219 for Adults With Focal Seizures
Tests RAP-219 for reducing seizures in adults with focal epilepsy.
Plain-language title generated from the registry record
Registry title: Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Key facts
- Where
- Plymouth, United KingdomSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07563881, who can take part
Where in United Kingdom
- University Hospitals Plymouth NHS TrustPlymouth, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rapport Therapeutics Inc.
- Trial code
- NCT07563881EU 2025-524847-11-01
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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.
Inclusion: 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: Known hypersensitivity or prior exposure to RAP-219; 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; Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur.