Sleep disturbance and learning in children with Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS)

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66730162

Enrollment

Registered

2011-07-13

Start date

2011-09-01

Completion date

Unknown

Last updated

2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS), also known as Benign Rolandic Epilepsy Nervous System Diseases Epilepsy

Interventions

1. Sulthiame versus placebo 2. Dose: 5 mg/kg/day 3. Administration: oral capsules, given at approximately 8 hour intervals 4. Duration: (Period A) 6 wee

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
1. Frequency of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS) on active treatment, relative to placebo, as measured by EEG at baseline, the end of treatment period A and the end of treatment period B 2. Sleep quality [efficiency, number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS on polysomnography] on active treatment relative to placebo, as measured at baseline, the end of treatment period A and the end of treatment period B 3. Performance on Consolidation of Learning (CoL) tasks on active treatment, relative to placebo, as measured (by validated CoL tools) at baseline, the end of treatment period A and at the end of treatment period B 4. Performance on cognitive assessments including IQ and event related potential (ERP) utilising the commonly employed auditory oddball paradigm as a measure of basic sensory processing and attention, as measured at baseline, the end of treatment period A and the end of treatment period B	—

Measure

Time frame

1. Frequency of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS) on active treatment, relative to placebo, as measured by EEG at baseline, the end of treatment period A and the end of treatment period B 2. Sleep quality [efficiency, number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS on polysomnography] on active treatment relative to placebo, as measured at baseline, the end of treatment period A and the end of treatment period B 3. Performance on Consolidation of Learning (CoL) tasks on active treatment, relative to placebo, as measured (by validated CoL tools) at baseline, the end of treatment period A and at the end of treatment period B 4. Performance on cognitive assessments including IQ and event related potential (ERP) utilising the commonly employed auditory oddball paradigm as a measure of basic sensory processing and attention, as measured at baseline, the end of treatment period A and the end of treatment period B

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026