Sleep and learning in children with a benign focal epilepsy of childhood.

Phase 1

• Conditions: Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS). (Also known as Benign Rolandic Epilepsy.); MedDRA version: 14.0 Level: PT Classification code 10070530 Term: Benign rolandic epilepsy System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-001571-39-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Male and female children 6–16 years of age
-Within 6 months of diagnosis with BECCTS and the onset of symptoms
-With clinical EEG characteristic consistent with typical BECCTS [16]
-With no current or prior treatment for BECCTS
-Signed informed (parental) consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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

-Inability to comply with assessments
-Any serious intercurrent illness or uncontrolled disease which could compromise participation in the study
-With contraindications for treatment with sulthiame:
-History of hypersensitivity to sulphonamides
-History of acute porphyria
-History of hyperthyroidism
-History of arterial hypertension
-Impaired renal function
-Psychiatric disorder
-Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose
malabsorption syndrome.

Study & Design

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