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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAP-219 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAP-219 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniela Moreno | Contact | (857) 323-9048 | dmoreno@rapportrx.com | |
| Beth Bowers | Contact | (857) 323-9048 | bbowers@rapportrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Imran Quraishi, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultants in Epilepsy and Neurology, PLLC | Recruiting | Boise | Idaho | 83702 | United States | |
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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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period. |
| Mayo Clinic |
| Recruiting |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| NYU Langone Comprehensive Epilepsy Center | Recruiting | New York | New York | 10016 | United States |
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania - Department of Neurology | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine | Recruiting | Houston | Texas | 770300 | United States |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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