Health Condition 1: G40- Epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Ethosuximide: Ethosuximide is started at 10 mg per kg day and hiked at weekly intervals upto a maximum tolerable dose or 30 mg per kg day in 4 weeks interval of titration phase. The sam
Sponsors
Child neurology division department of pediatrics AIIMS NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 4-12 years diagnosed with DEE-SWAS as per the study definition (sleep SWI more than 50 percentage ) 2. Children with DEE-SWAS who are steroid non-responders or relapsed on steroids as per the study definition. Steroid therapy will be defined as pulse methylprednisolone at 30mg per kg per day for 5 days followed by 6 weeks at 2mg per kg plus 6 weeks of tapering of oral steroids OR monthly 5-day pulses of MPS for three months without intervening steroids. This is derived from the current institutional protocol used for children with DEE-SWAS. 3. A period of at least three months have passed after the last dose of steroids
Exclusion criteria
Exclusion criteria: 1.Diagnosed progressive neurological disorder 2.Children who have received interventional drugs: ethosuximide or Perampanel in the past six months. 3.Children planned or being evaluated for epilepsy surgery. Secondary Exclusion Criteria: Applied after observation period a.Sleep SWI less than 50 percentage b.Change in antiseizure drug treatment other than use of rescue or abortive benzodiazepine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of children with steroid non responsive or relapsing DEE-SWAS who show electrographic response in SWI in sleep EEG between ethosuximide and standard treatment at 16 weeks+7 days of therapy 2.To compare the proportion of steroid non responsive or relapsing DEE-SWAS children who show electrographic response in SWI in sleep EEG between perampanel and standard treatment at 16 weeks+ 7 days of therapy Electrographic response will be defined as absolute reduction in SWI in drug induced sleep (daytime nap) EEG by 25 points from baseline. Timepoint: 16 weeks+7 days of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the mean change in PINACLE score from baseline to 16 weeks plus 7 days of therapy among ethosuximide, perampanel and standard armTimepoint: 16 weeks plus 7 days of therapy;To compare the mean change in SWI from baseline at 16 weeks plus 7 days of add-on ethosuximide or add on perampanel with standard arm in steroid non responsive/relapsing DEE SWASTimepoint: 16 weeks plus 7 days of therapy;To compare the proportion of children showing neurobehavioral response at 16 weeks plus 7 days of therapy with add on ethosuximide or add on perampanel with standard armTimepoint: 16 weeks plus 7 days of therapy;To compare the proportion of steroid non responsive or relapsing DEE SWAS children who show electrographic response in sleep EEG between ethosuximide and perampanel add on at 16 weeks plus 7 days of therapyTimepoint: 16 weeks plus 7 days of therapy;To study any change in functional circuitry of DEE SWAS using high density EEG at baseline and at 16 weeks plus 7 days of ethosuximide or perampanel add on therapy in 10 to 12 children in each group.Timepoint: 16 weeks plus 7 days of therapy;To study the adverse effect profile of ethosuximide and perampanel in children with DEE SWASTimepoint: throughout the study period | — |
Countries
India
Contacts
Public ContactDr Bayye Swapna
AIIMS NEW DELHI
Outcome results
None listed