Clinical trail in children with ESES syndrome

• Conditions: Electrical Status Epilepticus in Sleep (ESES); 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-GB
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-27
• Last Update Posted: 30 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:
o Bilateral sleep-induced epileptiform activity with SWI in > 85% of nonREM sleep and developmental delay, arrest, or regression (typical ESES syndrome”);
o Arrest or regression of development and bilateral sleep-induced epileptiform activity with a SWI in > 50%, or unilateral sleep induced epileptiform activity with SWI in > 85% of nonREM sleep (atypical ESES syndrome”);
o Regression of development and unilateral epileptiform activity with a SWI of > 50%
of nonREM sleep (atypical ESES syndrome”);
· 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; These drugs are known to possibly worsen the outcome in children with ESES syndrome and may therefore influence treatment result. Furthermore, these drugs can increase the SWI during sleep and may cause an electrographic pattern fulfilling the criteria for ESES. Inclusion of such cases with possible treatment induced ESES” is not desirable.
· Written informed consent by parents / legal representatives
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

· Patients with a 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