Treatment of ESES syndrome with corticosteroids or clobazam: a European study

Phase 1

• Conditions: Encephalopathy with electrical status epilepticus in sleep, also called ESES syndrome; MedDRA version: 20.0Level: LLTClassification code 10032061Term: Other forms of epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000531-27-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-09
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

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 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

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 steroids.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified