Childhood Absence Epilepsy Juvenile Absence Epilepsy
Conditions
Brief summary
Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14
Detailed description
1. Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG), 2. Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG), 3. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14, 4. Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12, 5. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12, 6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment, 8. Percentage of participants with serious adverse events (SAEs) during the study, 9. Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG), 2. Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG), 3. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14, 4. Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12, 5. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12, 6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study, 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment, 8. Percentage of participants with serious adverse events (SAEs | — |
Countries
Italy, Romania, Slovakia, Spain