A Phase 3 interventional study of RAP-219 and RAP-219 in Focal Seizure, Epilepsy and Focal Epilepsy, sponsored by Rapport Therapeutics Inc.. Recruiting at 14 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Rapport Therapeutics Inc. · Phase 3, Interventional, and Treatment
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.
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.
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 312 is above the median of 64 across 519 interventional studies indexed under Seizures.
Browse Seizures studies →Rapport Therapeutics Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical history of any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RAP-219 daily tablets administered orally
Drug: RAP-219
RAP-219 daily tablets administered orally
Drug: RAP-219
Inert comparator matching the active treatment
Other: Placebo
Median Percent Change in Seizure Frequency
Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates
Time frame: End of double-blind treatment period (end of week 14) vs Baseline
≥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
Time frame: 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
Time frame: Across the entire 14-week double-blind treatment period
Incidence of Adverse Events
incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and AEs leading to discontinuation
Time frame: From Visit 1 through End of Study, on average Week 22.
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2029, 34 months after the start.
Of 43 industry-sponsored phase 3 interventional studies under Seizures, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 79. This study's planned 34 months is below that.
Counting every sponsor, half of 51 studies reached it within 54 months; a quarter within 33 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: RAP-219
Rapport Therapeutics Inc.