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One of the largest clinical trials ever conducted on children with epilepsy, aimed at determining which treatment approach is most effective for children and their families, begins today.
The CASTLE National Trial (Program Change, Sleep, Treatment and Learning of Epilepsy in Children) is led by Professor Deb Pal of King's College London and Professor Paul Gringras of the Evelina London Children's Hospital. University of Exeter Medical School.
Funded by the National Institute of Health Research (NHIR), CASTLE is one of the only trials comparing antiepileptic drugs with active surveillance without medication. The program is also supported by the Universities of Liverpool, Edge Hill and Oxford Brookes.
The CASTLE trial kicks off on March 26th on the occasion of Purple Day, the epilepsy awareness day for families. 28 NHS Trusts from the UK have already registered. The researchers aim to enroll 300 children with rolandic epilepsy.
Rolandic epilepsy is the most common form of epilepsy in children, affecting approximately 10,000 young people in the UK. Epileptic seizures occur most often at night and affect children aged 5 to 12 before gradually decreasing in adolescence.
Treating epilepsy with medication to reduce seizures has always been the goal of medical treatment. However, medications used to treat epilepsy often slow down the child's thinking and learning. Because children with Rolandic epilepsy "come out" of their seizures, doctors and parents often do not know whether to treat children or not, and many families do not choose medication.
CASTLE's research program focuses on more than just crises. The study led by Professor Chris Morris has identified and prioritized the more general aspects of life with rolandic epilepsy that it is important for families to measure as results of life. test, such as learning, sleep, behavior, self-esteem and children's mood. This study also reviewed and recommended the best ways to measure the quality of life of children with epilepsy.
Professor Chris Morris, of Exeter University, said: "Young people with epilepsy, parents, and health professionals have been part of a systematic process to achieve a successful outcome. agreement on the most important aspects of health to measure in tests of treatments to improve the health and quality of drugs.The life of children with epilepsy.This ensures that the test focuses on what is most important to inform decision-makers of the opportunity to use treatments in the future. "
The trial will compare two licensed drugs, comparing their effects to active surveillance without medication. NICE guidelines recommend treatment with carbamazepine, a standard epileptic drug that is highly effective in preventing seizures, but may have negative effects on learning. A new drug called levetiracetam could be just as effective, but with no impact on learning, but has not been evaluated in a rigorous clinical trial on rolandic epilepsy.
Professor Deb Pal of the King & # 39; s Institute of Psychiatry, Psychology and Neuroscience, and co-head of the trial, said: "For the first time in a major trial, we take a very broad view of the results, going beyond crises We hope that the results will help prevent antiepileptic drugs do more harm than good to some children with epilepsy and help families to decide the best course of action. "
A second key goal of the CASTLE trial is to determine if improving sleep can reduce seizures. The researchers have come up with the world's first online intervention on sleep behaviors, especially for epilepsy, which teaches parents how to encourage good sleep in their children. The test will verify to what extent the intervention on sleep is working properly with and without medication for convulsions.
Professor Paul Gringras, of the Evelina London Children's Hospital, and co-head of the trial, said: "Sleep and seizures are intimate bed mates.There is a vicious circle in which seizures and medications can affect sleep, but a broken or insufficient sleep can This sleep disturbance has huge consequences for all families, mothers of epileptic children rarely spend more than four hours a night. simple but essential question: can improving a child's sleep reduce his seizures and improve his parents and themselves "well-being?"
The trial is funded at £ 2.3 million by the National Institute for Health Research. It brings together a great expertise of British research institutes, including the University of Liverpool, Edge Hill University, Exeter University, Oxford Brookes and Bangor.
Families interested in participating are encouraged to talk to their pediatrician or epilepsy nurse. More details on the participation are available online: http://castlestudy.org.uk/take-part/
Genes influence the timing of sleep and waking of seizures in people with epilepsy
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Trial to solve the dilemma of treating epilepsy in children (March 26, 2019)
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