RESCUE ESES: a Randomized European trial of Steroids versus Clobazam Usage for Encephalopathy with Electrical Status Epilepticus in Sleep

Not Applicable

Completed

• Conditions: Encephalopathy with electrical status epilepticus in sleep (ESES syndrome); Nervous System Diseases

• Registration Number: ISRCTN42686094
• Lead Sponsor: niversity Medical Center Utrecht (Netherlands)

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33228736/ protocol (added 25/11/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38081201/ (added 18/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-24
• Study Completion: 2023-07-31
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age 2 to 12 years
2. 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)
3. No previous treatment with anti-epileptic drugs in the context of ESES
4. No previous treatment with either clobazam or corticosteroids
5. No current treatment with carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin and pregabalin and no treatment with any of these drugs in the previous three months
6. Written informed consent by parents / legal representatives

Exclusion Criteria

1. Patients with a spike wave index during wakefulness of > 50%
2. 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
1. Intelligence quotient, or developmental quotient<br>2. Cognitive sumscore<br>Improvement is defined as significant when improved by at least 75% of the standard deviation.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will be evaluated after 6 and 18 months:<br>1. Individual absolute test results, and IQ scores<br>2. Spike wave index during Non-rapid eye movement (non-REM) sleep. Improvement is defined as a decrease to less than<br>25%<br>3. Seizure frequency. Improvement is defined as a reduction of 50% or more as compared with baseline<br>4. Safety and tolerability, as assessed by the occurrence of serious adverse events<br>5. Differences in pro-inflammatory cytokine levels in patients with ESES who respond to either treatment strategies compared to non responders<br><br>Added 28/02/2014:<br>6. Assessment of global daily functioning assessed with a visual analogue scale (VAS, -5 to 5)