RESCUE ESES: Randomized European Trial of Steroids versus Clobazam Usage for Encelopathy with ESES.

• Conditions: Encephalopathy with electrical status epielpticus in sleep, ESES syndrome.; MedDRA version: 17.1Level: LLTClassification code 10032061Term: Other forms of epilepsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000531-27-FI
• Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-16
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

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

Inclusion Criteria

-Age 2 up to 12 years (not including children of 12 years old);
-A diagnosis within six months prior to study inclusion (preferably as close to inclusion as possible) of either typical or atypical ESES syndrome (as defined in the study protocol)
-No previous treatment with either corticosteroids or clobazam
-No current treatment nor in the previous three months with carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin and pregabalin
-Written informed consent by parents / 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 (SWI) during wakefulness of > 50%
•Acute or chronic infectious disease (e.g. TB, HIV)
•Immunodeficiency
•Severe osteopenia/osteoporosis
•Diabetes
•Cushing syndrome
•Severe respiratory insufficiency
•Severe liver failure
•Severe ulcera
•Any other condition that, in the investigator’s judgement, contra-indicates the use of corticosteroids or clobazam.

Study & Design

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