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Clinical Trials/ISRCTN66730162
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.

Registry
who.int
Start Date
July 13, 2011
End Date
August 31, 2013
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Bristol (UK)

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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