Focal Onset SeizuresPhase 2NCT06377930
Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
A Phase 2 study testing RAP-219 in people with Focal Onset Seizures, run by Rapport Therapeutics Inc. at 12 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 if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Onset Seizures
- 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
- 12 sitesUnited States
- Study dates
- 10 Oct 2024to 26 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data
- If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations are allowed
- At least 1 clinical seizure during the 8-week retrospective eligibility period
- Participants in otherwise good health as determined by the investigator
- Willing and able to adhere to all aspects of the protocol
- A demonstrated history of compliance with interrogation of the RNS device and upload of data before screening
Who cannot join
- Participants with generalized onset seizures in the past 10 years
- History of status epilepticus while on antiseizure medications within 2 years of screening
- Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
- Participants who have had epilepsy surgery within the last 12 months before screening
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Consultants in Epilepsy and Neurology, PLLC
Boise, Idaho, 83702
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Baylor College of Medicine
Houston, Texas, 770300
University of Texas Health Science Center, Houston
Houston, Texas, 77030
IU Health Neuroscience Center, Goodman Hall
Indianapolis, Indiana, 46202
The University of Kansas Medical Center Epilepsy Clinic
Kansas City, Kansas, 66160
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06519
NYU Langone Comprehensive Epilepsy Center
New York, New York, 10016
University of Pennsylvania - Department of Neurology
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Phase 2A, Multicenter, Open-label Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
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 if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.
Read the detailed description
This is a Phase 2A, proof-of-concept, multi-center, open-label study designed to evaluate the efficacy, safety, tolerability, and PK/PD relationship of RAP-219 in adult participants with refractory focal epilepsy. The activity of RAP-219 will be assessed in approximately 30 participants treated with the RNS® system.
- Conditions
- Focal Onset Seizures
- Being tested
- RAP-219
- Keywords
- Epilepsy, RNS, long episode, FOS, Refractory focal epilepsy
- 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 oral tablet
| Study group | Role | What they receive |
|---|---|---|
| RAP-219 | Experimental | Participants will receive 0.75 mg RAP-219 daily for 5 days followed by 1.25 mg RAP-219 daily for the remainder of the 8-week treatment period. Receives: Drug: RAP-219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in long episode frequency during the treatment period compared to pre-treatment baseline: Responder proportion, Percent Change Percent change
Change in long episode frequency per 28-day period during the treatment period compared to baseline
Measured: Screening until 5 months after enrollment
Secondary outcomes (12)
Change in focal clinical seizure frequency during the treatment period compared to pre-treatment baseline: Percent Change, Responder proportion
Change in focal clinical seizure frequency per 28-day period during the treatment period compared to baseline
Measured: Screening until 5 months after enrollment
Change in frequency of estimated electrographic seizures based on RNS® system data during the treatment period compared to pre-treatment baseline
Change in the frequency per 28-day period of estimated electrographic seizures based on RNS data during the treatment period compared to baseline
Measured: Screening until 5 months after enrollment
Change in RNS® system long episode-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count
Change in long episode-free days during the treatment period compared to pre-treatment baseline
Measured: Screening until 5 months after enrollment
Change in focal clinical seizure-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count
Change in focal clinical seizure-free days during the treatment period compared to pre-treatment baseline
Measured: Screening until 5 months after enrollment
Change in RNS® system electrographic biomarkers other than long episodes during the treatment period compared to pre-treatment baseline
Change in RNS® system electrographic biomarkers other than long episodes during the treatment period compared to pre-treatment baseline
Measured: Dosing until 5 months after dosing
Change in the Seizure Severity Response Questionnaire (SSRQ) during the treatment period compared to pre-treatment baseline
Measurement of seizure severity by participant rating scale of the Seizure Severity Scale. Seizure severity will be assessed by asking participants to respond to 4 questions using a 0-10 numerical rating scale and circling the number that best describes how their seizures have impacted them since their last study visit. Higher scores = higher impact.
Measured: Screening until 5 months after enrollment
Count and proportion of responders on the clinical global impression of change (CGIC) scale during the treatment period compared to pre-treatment baseline
Change in overall clinical status as measured by Clinical Global Impression of Change scores rated by investigator and participant. Both the participant (PGIC) and the clinician (CGIC) will rate their global impression of changes in the participant's condition throughout the study. The CGI scale measures the change in the participant's clinical status from a specific point in time, i.e., the Baseline Period and is rated on a 7-point Likert scale ranging from a score of 1 for very much improved to 7 for very much worse. Higher scores = worse outcome.
Measured: Screening until 5 months after enrollment
Plasma concentrations of RAP-219
Analysis of plasma concentrations of RAP-219
Measured: Dosing until 5 months after dosing
Incidence of treatment-emergent adverse events (TEAEs)
Analysis of AEs during the treatment and pre-treatment baseline periods
Measured: Dosing until 5 months after enrollment
Clinically meaningful changes, if any, from baseline in vital signs, electrocardiograms (ECGs), complete blood counts, serum chemistries, or liver function tests after treatment with RAP-219
Analysis of vital signs, ECGs, CBC, serum chemistries and liver function tests during the treatment and pre-treatment baseline periods
Measured: Screening until 5 months after enrollment
Incidence of participants expressing suicidal ideation assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS)
Analysis of C-SSRS entries during the treatment and pre-treatment baseline periods
Measured: Screening until 5 months after enrollment
Cognitive function as measured using the Cogstate Digital Battery
Analysis of the Cogstate Digital Battery during the treatment and pre-treatment baseline periods
Measured: Screening until 5 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start10 Oct 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Onset SeizuresStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Rapport Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaqueline A French, MD, Principal investigator, NYU Langone Comprehensive Epilepsy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377930
- Sponsor's protocol ID
- RAP-219-FOS-201
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2024
- Last updated
- 5 Feb 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Multicenter, Open-label Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy
- ClinicalTrials.gov ID
- NCT06377930
- Acronym / sponsor ID
- RAP-219-FOS-201
- Conditions
- Focal Onset Seizures
- Keywords
- Epilepsy, RNS, long episode, FOS, Refractory focal epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rapport Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 22 Apr 2024 (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 if RAP-219 works and is safe in patients with Refractory Focal Epilepsy.
Detailed description
This is a Phase 2A, proof-of-concept, multi-center, open-label study designed to evaluate the efficacy, safety, tolerability, and PK/PD relationship of RAP-219 in adult participants with refractory focal epilepsy. The activity of RAP-219 will be assessed in approximately 30 participants treated with the RNS® system.
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-219Participants will receive 0.75 mg RAP-219 daily for 5 days followed by 1.25 mg RAP-219 daily for the remainder of the 8-week treatment period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medically refractory focal epilepsy with an implanted responsive neurostimulator device placed correctly in a seizure onset zone that meet several device-related criteria and demonstrated history of compliance with interrogation of the RNS device and upload of data
- If currently treated with antiseizure medications, up to a maximum of 4 concomitant mediations are allowed
- At least 1 clinical seizure during the 8-week retrospective eligibility period
- Participants in otherwise good health as determined by the investigator
- Willing and able to adhere to all aspects of the protocol
Key exclusion criteria (4 listed)
- Participants with generalized onset seizures in the past 10 years
- History of status epilepticus while on antiseizure medications within 2 years of screening
- Individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
- Participants who have had epilepsy surgery within the last 12 months before screening
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 oral tablet | Drug | RAP-219 |
Primary outcome
Change in long episode frequency during the treatment period compared to pre-treatment baseline: Responder proportion, Percent Change Percent change
Time frame: Screening until 5 months after enrollment
Change in long episode frequency per 28-day period during the treatment period compared to baseline
12 secondary outcomes
Change in focal clinical seizure frequency during the treatment period compared to pre-treatment baseline: Percent Change, Responder proportion
Time frame: Screening until 5 months after enrollment
Change in frequency of estimated electrographic seizures based on RNS® system data during the treatment period compared to pre-treatment baseline
Time frame: Screening until 5 months after enrollment
Change in RNS® system long episode-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count
Time frame: Screening until 5 months after enrollment
Change in focal clinical seizure-free days during the treatment period compared to pre-treatment baseline: Count, Longest continuous interval, Time until pre-treatment count
Time frame: Screening until 5 months after enrollment
Change in RNS® system electrographic biomarkers other than long episodes during the treatment period compared to pre-treatment baseline
Time frame: Dosing until 5 months after dosing
Change in the Seizure Severity Response Questionnaire (SSRQ) during the treatment period compared to pre-treatment baseline
Time frame: Screening until 5 months after enrollment
Count and proportion of responders on the clinical global impression of change (CGIC) scale during the treatment period compared to pre-treatment baseline
Time frame: Screening until 5 months after enrollment
Plasma concentrations of RAP-219
Time frame: Dosing until 5 months after dosing
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Dosing until 5 months after enrollment
Clinically meaningful changes, if any, from baseline in vital signs, electrocardiograms (ECGs), complete blood counts, serum chemistries, or liver function tests after treatment with RAP-219
Time frame: Screening until 5 months after enrollment
Incidence of participants expressing suicidal ideation assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening until 5 months after enrollment
Cognitive function as measured using the Cogstate Digital Battery
Time frame: Screening until 5 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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. This study is not recruiting at the moment.
Jaqueline A French, MD principal investigator
NYU Langone Comprehensive Epilepsy Center
12 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 Onset Seizures, run by Rapport Therapeutics Inc. at 12 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in long episode frequency during the treatment period compared to pre-treatment baseline: Responder proportion, Percent Change Percent change (time frame: Screening until 5 months after enrollment). 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 5 Feb 2026.