Treatment of ESES syndrome with corticosteroids or clobazam: a Europeanstudy
- Conditions
- Encephalopathy with electrical status epilepticus in sleep, also calledESES syndromeMedDRA version: 18.0Level: LLTClassification code 10032061Term: Other forms of epilepsySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-000531-27-FR
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 130
•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 steroids
•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/tutors or legal representatives
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Patients with a spike wave index during wakefulness of > 50%
•Any condition that, in the investigator's judgement, contraindicates the use of clobazam or steroids.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method