Focal SeizurePhase 3FOCUS 2NCT07594119
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
A Phase 3 study testing RAP-219 in people with Focal Seizure and Epilepsy, run by Rapport Therapeutics Inc. at 14 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
- 312 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 1 Sep 2026to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 2 countries
United States13 sites, 13 recruiting
- Recruiting
Pillar Clinical Research
Bentonville, Arkansas, 72712
- Recruiting
Re:Cognition Health-Chicago
Chicago, Illinois, 60611
- Recruiting
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80919
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
University of Texas Health Science Center in Houston
Houston, Texas, 77030
- Recruiting
Clinic for Neurology
Huntsville, Alabama, 35801
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
- Recruiting
Serenity Research Center, LLC
Miami, Florida, 33176
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37179
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68105
- Recruiting
Velocity Clinical Research
Raleigh, North Carolina, 27607
Australia1 site, 1 recruiting
- Recruiting
Eastern Health Clinical School, Monach University Box Hill
Melbourne
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 312 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (Medium Dosage, Low 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 medium dose tablets administered orally daily
RAP-219Drug
RAP-219 low dose tablets administered orally daily
PlaceboOther
Matching placebo tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Active Arm- Medium Dose | Experimental | RAP-219 daily tablets administered orally Receives: Drug: RAP-219 |
| Active Arm-Low 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 posted18 May 2026
- Study start1 Sep 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
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rapport Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicente Villaneuva, M.D., PhD, Principal investigator, Hospital Universitari i Politecnic La Fe, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594119
- Sponsor's protocol ID
- RAP-219-FOS-302
- Acronym
- FOCUS 2
- Status last verified
- Nov 2026
- First submitted
- 11 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07594119
- Acronym / sponsor ID
- FOCUS 2 / RAP-219-FOS-302
- Conditions
- Focal Seizure, Epilepsy, Focal Epilepsy
- Keywords
- Focal Preserved Consciousness, Focal Impaired Consciousness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Rapport Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 312 subjects will be randomized into one of two active treatment groups or placebo in a 1:1:1 randomization ratio (Medium Dosage, Low 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a placebo-controlled trial of active drug versus placebo.
| Arm | Type | Receives |
|---|---|---|
| Active Arm- Medium Dose | Experimental | Drug: RAP-219RAP-219 daily tablets administered orally |
| Active Arm-Low Dose | Experimental | Drug: RAP-219RAP-219 daily tablets administered orally |
| Placebo | Placebo comparator | Other: PlaceboInert comparator matching the active treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAP-219RAP-219 medium dose tablets administered orally daily | Drug | Active Arm- Medium Dose |
| RAP-219RAP-219 low dose tablets administered orally daily | Drug | Active Arm-Low Dose |
| PlaceboMatching placebo tablets administered orally | Other | Placebo |
Primary outcome
Median Percent Change in Seizure Frequency
Time frame: End of double-blind treatment period (end of week 14) vs Baseline
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates
2 secondary outcomes
≥50% seizure frequency reduction responder rates
Time frame: End of double-blind treatment period (end of week 14) vs Baseline.
Longest Seizure Free Interval
Time frame: Across the entire 14-week double-blind treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicente Villaneuva, M.D., PhD principal investigator
Hospital Universitari i Politecnic La Fe, Spain
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RAP-219 in people with Focal Seizure and Epilepsy, run by Rapport Therapeutics Inc. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rapport Medical (857 323 9048, RAP-219-FOS@rapportrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Percent Change in Seizure Frequency (time frame: End of double-blind treatment period (end of week 14) vs Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.