Extract

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 [email protected]

Inclusion criteria

• Benign Epilepsy of Childhood with Centrotemporal Spikes (BECCTS). (Also known as Benign Rolandic Epilepsy.)

Links

• ictrp
• isrctn