NCT07594119 Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
| NCT ID | NCT07594119 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rapport Therapeutics Inc. |
| Condition | Focal Seizure |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2026-06 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 312 participants in total. It began in 2026-06 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Vicente Villaneuva, M.D., PhD
PRINCIPAL INVESTIGATOR
Hospital Universitari i Politecnic La Fe, Spain
Frequently Asked Questions
Who can join the NCT07594119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Focal Seizure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07594119 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 312 participants.
Is NCT07594119 currently recruiting?
Yes, NCT07594119 is actively recruiting participants. Contact the research team at RAP-219-FOS@rapportrx.com for enrollment information.
Where is the NCT07594119 trial being conducted?
This trial is being conducted at Bentonville, United States, Maitland, United States.
Who is sponsoring the NCT07594119 clinical trial?
NCT07594119 is sponsored by Rapport Therapeutics Inc.. The principal investigator is Vicente Villaneuva, M.D., PhD at Hospital Universitari i Politecnic La Fe, Spain. The trial plans to enroll 312 participants.