Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1 (FOCUS 1)
August 31, 2026 updated by: Rapport Therapeutics Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
333
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rapport Medical
- Phone Number: 857 323 9048
- Email: RAP-219-FOS@rapportrx.com
Study Locations
-
-
California
-
Palmdale, California, United States, 91324
- Recruiting
- Amicis Research Center
-
-
Florida
-
Gulf Breeze, Florida, United States, 32561
- Recruiting
- Panhandle Research and Medical Clinic, LLC
-
-
Georgia
-
Atlanta, Georgia, United States, 30329
- Recruiting
- Emory Brain Health Center
-
-
Idaho
-
Boise, Idaho, United States, 83702
- Recruiting
- Consultants in Epilepsy & Neurology, PLLC
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46804
- Recruiting
- Indiana University Health Fort Wayne Neurology
-
-
Maryland
-
Bethesda, Maryland, United States, 20817
- Recruiting
- Mid-Atlantic Epilepsy and Sleep Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Northeast Regional Epilepsy Group
-
-
North Carolina
-
Asheville, North Carolina, United States, 28806
- Recruiting
- Asheville Neurology Specialists
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- Recruiting
- Cleveland Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Thomas Jefferson University
-
-
Virginia
-
Richmond, Virginia, United States, 23236
- Recruiting
- Neurological Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Inert comparator matching the active treatment
|
Matching placebo tablets administered orally daily
|
|
Experimental: Active Arm- High Dose
RAP-219 daily tablets administered orally
|
RAP-219 high dose tablets administered orally daily
RAP-219 medium dose tablets administered orally daily
|
|
Experimental: Active Arm- Medium Dose
RAP-219 daily tablets administered orally
|
RAP-219 high dose tablets administered orally daily
RAP-219 medium dose tablets administered orally daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
End of double-blind treatment period (end of week 14) vs Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
≥50% seizure frequency reduction responder rates
Time Frame: End of double-blind treatment period (end of week 14) vs Baseline.
|
Proportion of participants with at least 50% reduction from baseline in seizure frequency after treatment with RAP-219 compared with placebo
|
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
|
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo
|
Across the entire 14-week double-blind treatment period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RAP-219 safety and tolerability
Time Frame: From Visit 1 through End of Study, on average Week 22.
|
incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs leading to discontinuation
|
From Visit 1 through End of Study, on average Week 22.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2026
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
September 1, 2029
Study Registration Dates
First Submitted
April 16, 2026
First Submitted That Met QC Criteria
April 30, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
September 1, 2026
Last Update Submitted That Met QC Criteria
August 31, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAP-219-FOS-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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