EUCTR2011-001571-39-GB
Active, not recruiting
Phase 1
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 Cross-Over Trial. - Sleep Disturbance and Learning in BECCTS
niversity of Bristol0 sites20 target enrollmentAugust 16, 2011
DrugsOspolot
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Bristol
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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