Focal onset seizures or primary generalized tonic-clonic seizures.
Conditions
Brief summary
- Incidence and severity of treatment-emergent adverse events (TEAEs), including discontinuation of study drug due to TEAEs. - Changes in vital sign measurements. - Changes in clinical laboratory results. - Changes in electrocardiogram parameters. - Changes in suicidality, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Detailed description
(EXPLORATORY) Percent change in monthly (28 days) focal or generalized seizure frequency from the Screening/Observation Period of the primary trial., (EXPLORATORY) Changes in Patient Global Impression of Severity (PGI-S) and Clinical Global Impression of Severity (CGI-S)., (EXPLORATORY) Vormatrigine plasma concentrations
Interventions
DRUGPRAX-628
Sponsors
Praxis Precision Medicines Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence and severity of treatment-emergent adverse events (TEAEs), including discontinuation of study drug due to TEAEs. - Changes in vital sign measurements. - Changes in clinical laboratory results. - Changes in electrocardiogram parameters. - Changes in suicidality, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| (EXPLORATORY) Percent change in monthly (28 days) focal or generalized seizure frequency from the Screening/Observation Period of the primary trial., (EXPLORATORY) Changes in Patient Global Impression of Severity (PGI-S) and Clinical Global Impression of Severity (CGI-S)., (EXPLORATORY) Vormatrigine plasma concentrations | — |
Countries
Germany, Italy, Poland, Spain
Outcome results
None listed