Electrical Status Epilepticus in Sleep (ESES) epilepsy in sleep
Conditions
Interventions
Treatment with clobazam or corticosteroids.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: *Age 2 to 12 years *A diagnosis within six months prior to study inclusion (preferentially as soon as possible) of either typical or atypical ESES syndrome (as defined in study protocol) *No previous treatment with either clobazam or corticosteroids *No current treatment with carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin and pregabalin and no treatment with any of these drugs in the previous three months; *Written informed consent by parents / legal representatives.
Exclusion criteria
Exclusion criteria: *Patients with a spike wave index during wakefulness of > 50% *Any condition that, in the investigator*s judgement, contraindicates the use of clobazam or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Intelligence quotient, or developmental quotient - Cognitive sumscore Improvement is defined as significant when improved by at least 75% of the standard deviation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Individual absolute test results, and IQ scores; - Spike wave index during non-REM sleep. Improvement is defined as a rdecrease to less than 25%; - Seizure frequency. Improvement is defined as a reduction of 50% or more as compared with baseline; - Global improvement of functioning assessed with a VAS score (-5 to 5) - Safety and tolerability, as assessed by the occurrence of serious adverse events; - Differences in pro-inflammatory cytokine levels in patients with ESES who respond to either treatment strategies compared to nonresponders. Secondary outcomes will be evaluated after 6 and 18 months. | — |
Countries
Netherlands
Outcome results
None listed