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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm- Medium Dose | Experimental | RAP-219 daily tablets administered orally |
|
| Active Arm-Low Dose | Experimental | RAP-219 daily tablets administered orally |
|
| Placebo | Placebo Comparator | Inert comparator matching the active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAP-219 | Drug | RAP-219 medium dose tablets administered orally daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percent Change in Seizure Frequency | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ≥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 | End of double-blind treatment period (end of week 14) vs Baseline. |
| Longest Seizure Free Interval |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | 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. |
Inclusion Criteria:
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:
Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rapport Medical | Contact | 857 323 9048 | RAP-219-FOS@rapportrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Vicente Villaneuva, M.D., PhD | Hospital Universitari i Politecnic La Fe, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pillar Clinical Research | Recruiting | Bentonville | Arkansas | 72712 | United States | |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a placebo-controlled trial of active drug versus placebo.
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| RAP-219 |
| Drug |
RAP-219 low dose tablets administered orally daily |
|
| Placebo | Other | Matching placebo tablets administered orally |
|
To evaluate the longest seizure-free interval after treatment with RAP-219 compared with placebo |
| Across the entire 14-week double-blind treatment period |
| Colorado Springs Neurological Associates |
| Recruiting |
| Colorado Springs |
| Colorado |
| 80919 |
| United States |
| K2 Medical Research | Recruiting | Maitland | Florida | 32751 | United States |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |