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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42686094

Enrollment

130

Registered

2013-05-24

Start date

2014-07-21

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Encephalopathy with electrical status epilepticus in sleep (ESES syndrome) Nervous System Diseases

Interventions

Corticosteroids (either methylprednisolone pulse therapy or continuous oral prednisolone, depending on local preference) or clobazam.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Intelligence quotient, or developmental quotient 2. Cognitive sumscore Improvement is defined as significant when improved by at least 75% of the standard deviation.	—

Secondary

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

Measure

Time frame

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

—

Countries

Belgium, Bulgaria, Denmark, Finland, France, Germany, Italy, Netherlands, Romania, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026