Focal EpilepsyPhase 2NCT07219407
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
A Phase 2 study testing RAP-219 in people with Focal Epilepsy and Epilepsy, run by Rapport Therapeutics Inc. at 7 sites in United States.
Trial summary
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy
- What is being tested?
- RAP-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Dec 2025to 3 Feb 2028
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
- Diagnosis of refractory focal epilepsy
- Stable RNS(c) system settings
- A demonstrated history of compliance with RNS(c) system data interrogation and upload
- Good overall health other than focal epilepsy, per Investigator.
- BMI ≥ 18 kg/m^2 and ≤ 45 kg/m^2
- Willing and able to adhere to all aspects of the protocol.
Who cannot join
- Known of hypersensitivity to RAP-219
- Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Baylor College of Medicine
Houston, Texas, 770300
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
NYU Langone Comprehensive Epilepsy Center
New York, New York, 10016
- Recruiting
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
Read the detailed description
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures
- Conditions
- Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy, Seizure, Focal Seizure, Focal Onset Seizure
- Being tested
- RAP-219
- Keywords
- Focal Seizures, Epilepsy, RNS, Long episode
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAP-219Drug
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| RAP-219 | Experimental | Not described Receives: Drug: RAP-219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112
Secondary outcomes (13)
Percent change in clinical seizure frequency
Group median percent change in clinical seizure frequency per 28-day period as reported in a clinical seizure diary
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Clinical seizure 25%, 50%, 75%, and 100% responder proportions
Proportion of participants with at least 25%, 50%, 75%, or with 100% reduction in clinical seizure frequency per 28-day period as reported in a clinical seizure diary
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Change in clinical seizure-free day frequency
Group median change in clinical seizure-free day frequency per 28-day period as reported in a clinical seizure diary
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Longest clinical seizure-free interval
Duration, in days, of the longest continuous period of clinical seizure-free days per period as reported in a clinical seizure diary
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Time to pre-randomization clinical seizure count
Duration, in days, between the beginning of the open-label treatment period and the nth clinical seizure, where n is the number of clinical seizures per 28-day period during the prospective pre-treatment baseline period, as reported in a clinical seizure diary
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
RNS long episode 30%, 50%, 75% or with 100% responder proportions
Proportion of participants with at least 30%, 50%, 75%, and 100% reduction in long episodes per 28-day period as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Percent change in RNS long episode frequency
Group median percent change in long episode frequency per 28-day period as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Change in RNS long episode-free day frequency
Group median change in long episode-free day frequency per 28-day period as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Longest RNS long episode-free interval
Duration, in days, of the longest continuous period of long episode-free days per period as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Time to pre-randomization long episode count
Duration, in days, between the beginning of the open-label treatment period and the mth long episode, where m is the number of long episodes per 28-day period during the pre-treatment baseline period, as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Percent change in RNS estimated electrographic seizure frequency
Group median percent change in estimated electrographic seizure frequency per 28-day period as recorded by the RNS® System
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Clinical Global Impression of Change (CGI-C) responder count and proportions
Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Clinical Global Impression of Change (CGI-C) scale
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Patient Global Impression of Change [PGI-C] responder count and proportions
Count and proportion of participants with any improvement (minimally improved, much improved, or very much improved) or clinically meaningful improvement (much improved or very much improved) as reported on the Patient Global Impression of Change (PGI-C) scale
Measured: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start15 Dec 2025
- Primary completion3 Feb 2028 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rapport Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imran Quraishi, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219407
- Sponsor's protocol ID
- RAP-219-FOS-901
- Status last verified
- Jan 2026
- First submitted
- 8 Oct 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
- ClinicalTrials.gov ID
- NCT07219407
- Acronym / sponsor ID
- RAP-219-FOS-901
- Conditions
- Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy, Seizure, Focal Seizure, Focal Onset Seizure
- Keywords
- Focal Seizures, Epilepsy, RNS, Long episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rapport Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 3 Feb 2028 (estimated)
- Study completion
- 3 Feb 2028 (estimated)
- First posted
- 21 Oct 2025 (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 patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
Detailed description
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAP-219 | Experimental | Drug: RAP-219 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
- Diagnosis of refractory focal epilepsy
- Stable RNS(c) system settings
- A demonstrated history of compliance with RNS(c) system data interrogation and upload
- Good overall health other than focal epilepsy, per Investigator.
Key exclusion criteria (3 listed)
- Known of hypersensitivity to RAP-219
- Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
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-219Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period. | Drug | RAP-219 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112
13 secondary outcomes
Percent change in clinical seizure frequency
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Clinical seizure 25%, 50%, 75%, and 100% responder proportions
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Change in clinical seizure-free day frequency
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Longest clinical seizure-free interval
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Time to pre-randomization clinical seizure count
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
RNS long episode 30%, 50%, 75% or with 100% responder proportions
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Percent change in RNS long episode frequency
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Change in RNS long episode-free day frequency
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Longest RNS long episode-free interval
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Time to pre-randomization long episode count
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Percent change in RNS estimated electrographic seizure frequency
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Clinical Global Impression of Change (CGI-C) responder count and proportions
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
Patient Global Impression of Change [PGI-C] responder count and proportions
Time frame: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline 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 23 Jan 2026.
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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.
Imran Quraishi, MD principal investigator
Yale University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RAP-219 in people with Focal Epilepsy and Epilepsy, run by Rapport Therapeutics Inc. at 7 sites in United States.
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 7 inclusion and 3 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 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Daniela Moreno ((857) 323-9048, dmoreno@rapportrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112). 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 23 Jan 2026.