ISRCTN66730162
Terminated
未知
Investigating the relationship between sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS): a randomised double blind placebo controlled crossover trial
niversity of Bristol (UK)0 sites2 target enrollmentJuly 13, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS), also known as Benign Rolandic Epilepsy
- Sponsor
- niversity of Bristol (UK)
- Enrollment
- 2
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female children 6?16 years of age
- •2\. Within 6 months of diagnosis with BECCTS and the onset of symptoms
- •3\. With clinical electroencephalography (EEG) characteristic consistent with typical BECCTS
- •4\. With no current or prior treatment for BECCTS
- •5\. Signed informed (parental) consent
Exclusion Criteria
- •1\. Inability to comply with assessments
- •2\. Any serious intercurrent illness or uncontrolled disease which could compromise participation in the study
- •3\. With contraindications for treatment with sulthiame:
- •3\.1\. History of hypersensitivity to sulphonamides
- •3\.2\. History of acute porphyria
- •3\.3\. History of hyperthyroidism
- •3\.4\. History of arterial hypertension
- •3\.5\. Impaired renal function
- •3\.6\. Psychiatric disorder
- •3\.7\. Hereditary galactose intolerance, Lapp lactase deficiency, glucose\-galactose malabsorption syndrome
Outcomes
Primary Outcomes
Not specified
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