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Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
An open label extension clinical trial to assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label 30 mg/day vormatrogine for up to 2 years | Experimental | Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vormatrogine | Drug | Once daily oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | Change in tympanic temperature in Celsius | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | Change in heart rate in beats per minute | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | Change in blood pressure in mm/Hg | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | Change in respiratory rate in breaths per minute | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures | The principal investigator (PI) or sub investigator will review the laboratory report and document this review. Any clinically significant adverse changes occurring during the clinical trial will be documented as adverse events. | Up to 2 years |
| To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Praxis Precision Medicines | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Research Site | Miami Lakes | Florida | 33016 | United States | ||
| Praxis Research Site |
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Incidence of clinically significant ECG abnormalities |
| Up to 2 years |
| Naples |
| Florida |
| 34116 |
| United States |
| Praxis Research Site | Lafayette | Louisiana | 70508 | United States |
| Praxis Research Site | Bethesda | Maryland | 20817 | United States |
| Praxis Research Site | Chesterfield | Missouri | 63005 | United States |
| Praxis Research Site | Amherst | New York | 14226 | United States |
| Praxis Research Site | Middletown | New York | 10941 | United States |
| Praxis Research Site | El Paso | Texas | 79912 | United States |
| Praxis Research Site | Houston | Texas | 77058 | United States |
| Praxis Research Site | Bielefeld | 33617 | Germany |
| Praxis Research Site | Tübingen | 72076 | Germany |
| Praxis Research Site | Milan | 20133 | Italy |
| Praxis Research Site | Pavia | 27100 | Italy |
| Praxis Research Site | Bydgoszcz | 85163 | Poland |
| Praxis Research Site | Katowice | 40123 | Poland |
| Praxis Research Site | Barcelona | 08003 | Spain |
| Praxis Research Site | Madrid | 28040 | Spain |
| Praxis Research Site | Málaga | 29010 | Spain |
| Praxis Research Site | Terrassa | 08222 | Spain |
| Praxis Research Site | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D004830 | Epilepsy, Tonic-Clonic |
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| 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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