Condition category
Nervous System Diseases
Date applied
11/05/2011
Date assigned
13/07/2011
Last edited
29/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Benign epilepsy of childhood with centrotemporal spikes (BECCTS), also known as Benign Rolandic epilepsy, is one of the most common types of epilepsy in children. Unlike many other forms of epilepsy, BECCTS only affects children and the associated seizures usually disappear by the time the child is 16 years old. In most cases these seizures only happen when the child is asleep and do not last for very long. It has been found that sleep and drowsiness causes a surge of electrical activity in the centrotemporal region of the brain (centrotemporal spike). This form of epilepsy was previously considered to be harmless (benign) because it was thought to have no long-term ill-effects. However recent studies have shown that children who suffer from BECCTS may have mild learning difficulties. The exact cause of this is not known, as it could be due to the abnormal electrical activity in the brain or because of general interference with sleep. Sulthiame is an anticonvulsant drug which could be used to prevent these centrotemporal spikes, and helping to prevent sleep disturbances. The aim of this study is to find out if treatment with sulthiame could help to improve quality of sleep and help children to improve their learning skills.

Who can participate?
Children between the ages of 6 and 16 who have been diagnosed with BECCTS within the last 6 months.

What does the study involve?
Participants are randomly allocated into two groups, who each receive the treatments in a different order. Participants either take sulthiame for six weeks and then the placebo (dummy pill) for six weeks, or take the placebo for six weeks and then six weeks taking sulthiame. The correct dose of sulthiame is calculated for every child using their body weight. Between the sulthiame and placebo treatments, participants have a period of two weeks taking no medication (wash-out period). Before and after each of the treatments, children have their brain waves monitored during sleep and are given a number of tests to find out if their learning has improved.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Bristol Royal Hospital for Children (UK)

When is the study starting and how long is it expected to run for?
September 2011 to August 2013

Who is funding the study?
1. Epilepsy Research UK (UK)
2. Waterloo Foundation (UK)

Who is the main contact?
Dr Finbar O’Callaghan
finbar.ocallaghan@bristol.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Finbar O'Callaghan

ORCID ID

Contact details

Level 6 Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
+44 (0)117 342 0202
finbar.ocallaghan@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1260

Study information

Scientific title

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

Acronym

BECCTS

Study hypothesis

1. There will be an association between indices of sleep quality and strength of nocturnal versus daytime Consolidation of Learning in children with untreated BECCTS
2. Treatment of BECCTS will lead to the following changes relative to placebo:
2.1. Abolition of Interictal Epileptic Discharges (IEDs) during slow wave sleep (SWS)
2.2. Improved sleep quality [increased efficiency, reduced number of awakenings, density of sleep spindles and percentage rapid eye movement (REM) and percentage SWS]
2.3. Improved Consolidation of Learning (CoL)

Ethics approval

South West Research Ethics Committee (Central Bristol), 31/10/21011, ref: 11/SW/0136

Study design

Randomised double blind placebo controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Intervention

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 weeks of sulthiame or placebo, followed by a 2-week wash-out period, followed by (Period B) 6 weeks on the alternate treatment

Intervention type

Drug

Phase

Not Applicable

Drug names

Sulthiame

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

01/09/2011

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/09/2011

Recruitment end date

31/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Level 6 Education Centre
Bristol
BS2 8AE
United Kingdom

Sponsor information

Organisation

University of Bristol (UK)

Sponsor details

Research & Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

http://www.bristol.ac.uk/red/

Funders

Funder type

Charity

Funder name

Epilepsy Research UK (UK)

Alternative name(s)

ERUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Waterloo Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes