Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial

Completed

Conditions: Electrical Status Epilepticus in Sleep (ESES)
epilepsy in sleep
10039911

Registration Number: NL-OMON55462

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

*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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Intelligence quotient, or developmental quotient<br /><br>- Cognitive sumscore<br /><br>Improvement is defined as significant when improved by at least 75% of the<br /><br>standard deviation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Individual absolute test results, and IQ scores;<br /><br>- Spike wave index during non-REM sleep. Improvement is defined as a rdecrease<br /><br>to less than<br /><br>25%;<br /><br>- Seizure frequency. Improvement is defined as a reduction of 50% or more as<br /><br>compared with<br /><br>baseline;<br /><br>- Global improvement of functioning assessed with a VAS score (-5 to 5)<br /><br>- Safety and tolerability, as assessed by the occurrence of serious<br /><br>adverse events;<br /><br>- Differences in pro-inflammatory cytokine levels in patients with ESES<br /><br>who respond to either treatment strategies compared to nonresponders.<br /><br>Secondary outcomes will be evaluated after 6 and 18 months.</p><br>