Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than or equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Valproate monotherapy upto 1500mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to valproate. 2) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing nonresponsiveness to Levetiracetam monotherapy upto 1000mg per day, with less than equal to 50% change in seizure frequency for every month and had brivaracetam being added to levetiracetam. 3) Male or female patients between 18 to 65 years who are known cases of PGTCS patients with consistent EEG spike wave discharges at diagnosis having atleast greater than equal to 1 unprovoked generalized tonic clonic seizures showing behavioural adverse effects with levetiracetam and requiring treatment replacement with brivaracetam. 4) Clinical cases receiving brivaracetam for PGTCS with follow-up data for 12 weeks.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to Brivaracetam 2) Cases with structural lesion, diagnosis of Lennox Gastaut Syndrome, JAE, CAE and,or JME. 3) Lack of EEG corroboration 4) Cases with preceding or pre existing unstable medical, psychiatric or cardiovascular condition that could jeopardize or would compromise the subjects ability to participate in this study. 5) Cases without 12 weeks follow up data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Percent change in Seizure frequency every month at 12W based on patient diary. 2) Percent change in Seizure frequency from combined baseline to 12W for patients with GTCS.Timepoint: Baseline, 4 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate for treatment naïve or uncontrolled casesTimepoint: 4 weeks, 12 weeks;More than equal to 50% responder rate in PGTCS frequency per monthTimepoint: Baseline, 4 and 12 weeks;Physician Assessment of EffectivenessTimepoint: 12 weeks;Seizure freedom rateTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Neeraj Jain
Yardi Hospital
Outcome results
None listed