A trial to uncover which epilepsy treatment approach works best for children and their families has been launched to coincide with Purple Day, an international family-focused epilepsy awareness day.
The nationwide Changing Agendas on Sleep, Treatment and Learning in Childhood Epilepsy (CASTLE) trial is led by Professor Deb Pal from King’s College London and Professor Paul Gringras from the Evelina London Children’s Hospital, with a key preparation study led by Professor Chris Morris of the University of Exeter Medical School’s Peninsula Childhood Disability Unit in collaboration with PenCLAHRC’s Evidence Synthesis Team.
Funded by the National Institute for Health Research (NHIR), CASTLE is one of the only trials to compare antiepileptic drugs against active monitoring with no medication. 28 NHS Trusts across the U.K. have already signed up to take part and researchers are aiming to enrol 300 children with Rolandic epilepsy - the most common form of childhood epilepsy.
Treating epilepsy with drugs to reduce seizures has traditionally been the goal of medical treatment. However, these drugs can often slow down a child’s thinking and learning. Because children with Rolandic epilepsy ‘grow out’ of their seizures, doctors and parents often don’t know whether to treat children or not, and many families choose no medication.
The CASTLE research programme focuses on more than seizures. The study, led by Professor Chris Morris, identified and prioritised wider aspects of living with Rolandic epilepsy that are of importance to families - such as children's learning, sleep, behaviour, self-esteem and mood - as outcomes to measure in the trial. The study also reviewed and recommended the best ways to measure quality of life for children with epilepsy.
Professor Chris Morris says: ‘Young people with epilepsy, parents and health professionals took part in a systematic process to reach agreement about the most important aspects of health to measure in trials of treatments aiming to improve the health and quality of life of children with epilepsy. This ensures the trial focuses on what is most important to inform decisions about whether to use treatments in the future.’
The trial will compare two licensed drugs, comparing their effects to active monitoring with no medication. Professor Deb Pal from the Institute of Psychiatry, Psychology & Neuroscience at King’s, and co-leader of the trial, says: ‘For the first time in a major trial we are taking a very broad view of outcomes, looking beyond seizures to learning and a host of other issues that are important to young people and their parents. We hope the results will put to bed the notion of whether antiepileptic drugs cause more harm than good for some children with epilepsy, and help families decide the best course of action.’
A second key aim of the trial is testing whether improving sleep can reduce seizures. The researchers have developed the world’s first online sleep behaviour intervention especially for epilepsy, which teaches parents how to encourage good sleep in their children. The trial will test how well the sleep intervention works both with and without medication for seizures.
Professor Paul Gringras from Evelina London Children’s Hospital, and co-leader of the trial, says: ‘Sleep and seizures are intimate bedfellows. There is a vicious cycle whereby seizures and medications can affect sleep, but broken or insufficient sleep can also increase likelihood of seizures. This sleep disruption has huge impact on whole families, with mothers of children with epilepsy rarely getting more than four hours a night. We are asking a simple but vital question - can improving a child’s sleep reduce their seizures and improve their and their parents' well-being?’
The trial is funded by £2.3 million from the National Institute of Health Research and brings together a wealth of expertise from UK research institutions, including the University of Liverpool, Edge Hill University, the University of Exeter, Oxford Brookes University and Bangor University.
Families interested in taking part are encouraged to speak to their paediatrician or epilepsy nurse. More details on taking part are available online: http://castlestudy.org.uk/take-part/