Focal SeizurePhase 3FOCUS 1NCT07563881
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
A Phase 3 study testing RAP-219 in people with Focal Seizure and Epilepsy, run by Rapport Therapeutics Inc. at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Focal Seizure, Epilepsy, Focal Epilepsy
- What is being tested?
- RAP-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 5 Jun 2026to Sep 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Asheville Neurology Specialists
Asheville, North Carolina, 28806
- Recruiting
Emory Brain Health Center
Atlanta, Georgia, 30329
- Recruiting
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
- Recruiting
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, 83702
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44109
- Recruiting
Indiana University Health Fort Wayne Neurology
Fort Wayne, Indiana, 46804
- Recruiting
Panhandle Research and Medical Clinic, LLC
Gulf Breeze, Florida, 32561
- Recruiting
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
- Recruiting
Institute of Neurology and Neurosurgery at St. Barnabas
Livingston, New Jersey, 07039
- Recruiting
NYU Langone Health - Comprehensive Epilepsy Center
New York, New York, 10016
- Recruiting
Amicis Research Center
Palmdale, California, 91324
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
Neurological Associates
Richmond, Virginia, 23236
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
South Korea3 sites, 3 recruiting
- Recruiting
Dong-A University Hospital
Busan, Republic of Korea, 49201
- Recruiting
Korea University Anam Hospital
Seoul, Republic of Korea, 02841
- Recruiting
Seoul National University Hospital
Seoul, Republic of Korea, 03080
About this study
Official title: 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.
Read the detailed description
Approximately 333 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (High Dosage, Medium Dosage and Placebo). After completing the Double-blind Treatment Period, participants will either transition into the RAP-219-FOS-901 long-term safety (open-label extension) study or enter the 8-week post-treatment Follow-up Period of this study.
- Conditions
- Focal Seizure, Epilepsy, Focal Epilepsy
- Being tested
- RAP-219, Placebo
- Keywords
- Focal Preserved Consciousness, Focal Impaired Consciousness
- Medical subject headings
- Seizures, Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAP-219Drug
RAP-219 high dose tablets administered orally daily
RAP-219Drug
RAP-219 medium dose tablets administered orally daily
PlaceboOther
Matching placebo tablets administered orally daily
| Study group | Role | What they receive |
|---|---|---|
| Active Arm- High Dose | Experimental | RAP-219 daily tablets administered orally Receives: Drug: RAP-219 |
| Active Arm- Medium Dose | Experimental | RAP-219 daily tablets administered orally Receives: Drug: RAP-219 |
| Placebo | Placebo comparator | Inert comparator matching the active treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Percent Change in Seizure Frequency
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates:
Measured: End of double-blind treatment period (end of week 14) vs Baseline
Secondary outcomes (2)
≥50% seizure frequency reduction responder rates
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
Measured: End of double-blind treatment period (end of week 14) vs Baseline.
Longest Seizure Free Interval
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
Measured: Across the entire 14-week double-blind treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 Jun 2026
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a placebo-controlled trial of active drug versus placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rapport Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563881
- Sponsor's protocol ID
- RAP-219-FOS-301
- Acronym
- FOCUS 1
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No