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The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VX-765 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-765 | Drug | 300mg Oral Tablet, 900mg TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in seizure frequency | 6 weeks | |
| Percent of subjects with 50% or greater reduction in seizure frequency | 6 weeks | |
| Percent of subjects that become seizure free |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Wright, MD, PhD | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas | Little Rock | Arkansas | United States | |||
| California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37842826 | Derived | Panebianco M, Walker L, Marson AG. Immunomodulatory interventions for focal epilepsy. Cochrane Database Syst Rev. 2023 Oct 16;10(10):CD009945. doi: 10.1002/14651858.CD009945.pub3. |
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| 2 weeks |
| Percent of subjects who discontinue study drug treatment | 6 weeks |
| Plasma levels of study drug and other concomitant antiepileptic drugs | 13 weeks |
| Newport Beach |
| California |
| United States |
| Florida | Miami | Florida | United States |
| Florida | Sarasota | Florida | United States |
| Illinois | Chicago | Illinois | United States |
| Maryland | Baltimore | Maryland | United States |
| Maryland | Bethesda | Maryland | United States |
| Missouri | Chesterfield | Missouri | United States |
| New Jersey | Hackensack | New Jersey | United States |
| New York | New York | New York | United States |
| Pennsylvania | Philidelphia | Pennsylvania | United States |
| Virginia | Charlottesville | Virginia | United States |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C520022 | belnacasan |
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