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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001571-39-GB

Enrollment

Registered

2011-08-16

Start date

2011-10-31

Completion date

Unknown

Last updated

2019-11-25

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.) MedDRA version: 14.0 Level: PT Classification code 10070530 Term: Benign rolandic epilepsy System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Ospolot Product Name: sulthiame (trade name Ospolot) Pharmaceutical Form: Capsule INN or Proposed INN: sulthiame CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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 F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: None; Timepoint(s) of evaluation of this end point: 1. After 6 weeks on treatment A, and 2. (Following the cross-over to treatment B) After 6 weeks on treatment B. ; Main Objective: The overall research objective is to investigate the relationships between interictal epileptiform discharges (abnormal electrical activity in the brain), sleep quality, and consolidation of learning in children with untreated Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS). The specific research questions are: 1. Is there an association between indices of sleep quality and strength of nocturnal vs. daytime Consolidation of Learning in children with untreated BECCTS? 2. Does treatment of BECCTS lead to the following changes relative to placebo: a. Abolition of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS)? b. Improved sleep quality (increased efficiency, reduced number of awakenings, density of sleep spindles and %REM and %SWS)? c. Improved Consolidation of Learning (CoL)? ; Primary end point(s): 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 %REM and %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 the end of treatment period B. 4.Performance on cognitive asses	—

Measure

Time frame

Secondary Objective: None; Timepoint(s) of evaluation of this end point: 1. After 6 weeks on treatment A, and 2. (Following the cross-over to treatment B) After 6 weeks on treatment B. ; Main Objective: The overall research objective is to investigate the relationships between interictal epileptiform discharges (abnormal electrical activity in the brain), sleep quality, and consolidation of learning in children with untreated Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS). The specific research questions are: 1. Is there an association between indices of sleep quality and strength of nocturnal vs. daytime Consolidation of Learning in children with untreated BECCTS? 2. Does treatment of BECCTS lead to the following changes relative to placebo: a. Abolition of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS)? b. Improved sleep quality (increased efficiency, reduced number of awakenings, density of sleep spindles and %REM and %SWS)? c. Improved Consolidation of Learning (CoL)? ; Primary end point(s): 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 %REM and %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 the end of treatment period B. 4.Performance on cognitive asses

—

Secondary

Measure	Time frame
Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none	—

Countries

United Kingdom

Outcome results

None listed

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