Dravet Syndrome
Conditions
Brief summary
Frequency percent change in countable motor seizures during Maintenance compared to Baseline
Detailed description
Safety laboratory parameters, Physical examination findings, Vital signs, Growth parameters (height and weight), 12-lead Electrocardiogram (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) responses, Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score, 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Maintenance compared to Baseline, Frequency percent change in countable motor seizures during Treatment compared to Baseline
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency percent change in countable motor seizures during Maintenance compared to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety laboratory parameters, Physical examination findings, Vital signs, Growth parameters (height and weight), 12-lead Electrocardiogram (ECGs), Columbia-Suicide Severity Rating Scale (C-SSRS) responses, Patient Health Questionnaire-9 (PHQ-9) total score and Question 9 score, 50% responder rate (the percentage of participants with a ≥50% reduction in countable motor seizures) during Maintenance compared to Baseline, Frequency percent change in countable motor seizures during Treatment compared to Baseline | — |
Countries
Belgium, France, Germany, Italy, Latvia, Netherlands, Portugal, Spain