Randomised Factorial Design Controlled Trial Comparing Carbamazepine, Levetiracetam or Active Monitoring Combined With or Without Sleep Behaviour Intervention in Treatment Naive Children With Rolandic Epilepsy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Time to 6-month seizure remission
研究概览
简要总结
Rolandic epilepsy (RE) is the most common type of epilepsy. Children with RE have seizures and can often find that their learning, sleep, behaviour, self-esteem and mood are affected.
As part of standard NHS care, children diagnosed with RE may be treated with standard anti-epileptic medicines, like carbamazepine, or no medicine at all. The medicines used to treat epilepsy often slow down a child's thinking and learning. In the past, doctors believed this was an acceptable price to pay to reduce seizures. However, with RE, where the seizures usually stop in teenage years, investigators do not know if it is better to treat these children with medicines or not, especially if the medicines might have a negative effect on their learning.
A newer medicine called levetiracetam has also been found to work in children with RE and has shown less problems with thinking and learning in adults. However, it is still no known if this is also the case for children and it has not been proven which of the three options (carbamazepine, levetiracetam or no treatment) would be best for RE patients. The CASTLE study aims to find this out.
In addition, it has been found that seizures often happen when a child has had poor sleep and they often come at night or early in the morning. It has been shown that sleep can be improved through practice without the need of medicines. There are established guidelines to help toddlers go to sleep, but nothing available that helps young people with epilepsy and their parents improve their sleep quality. In the CASTLE study, a sleep training plan has been developed for children with epilepsy and the trial aims to find out whether following this sleep training plan results in less seizures than using no sleep training at all.
详细描述
The trial is a phase IV randomised factorial design controlled trial comparing carbamazepine, levetiracetam or active monitoring combined with or without sleep behaviour intervention. A factorial trial design has been used as this approach enables the efficient simultaneous investigation of AED (carbamazepine; levetiracetam; no AED) and sleep behaviour intervention (vs standard care) by including all participants in both analyses. In a factorial trial it is also possible to consider both the separate effects of each intervention and the benefits of receiving both interventions together (for example levetiracetam and sleep intervention).
The CASTLE trial will take place in NHS out-patient paediatric epilepsy and general paediatric clinics in the United Kingdom (UK).
Once consent has been obtained from the appropriate adult, and assent from the child if appropriate, by the delegated member of the research team the eligibility assessments will be completed, full eligibility confirmed (confirmation must be by a medically qualified doctor) and baseline data will be collected prior to randomisation.
Randomisation will be performed via a web based tool accessed by research team at site. This system is generated centrally by the Clinical Trial Research Centre (CTRC) using a computer algorithm concealed from the investigators and research teams/trial management group. In order to balance the groups, minimisation for variables believed to influence disease outcome and end points will be built into the randomisation algorithm.
Participants will be randomised to treatment with carbamazepine, levetiracetam or active monitoring. Where randomised to drug treatment, the randomised treatment should ideally begin on the day of randomisation or within 14 days of randomisation at the latest. Randomised treatment will continue for a minimum of 12 months and a maximum of 48 months. All treatments will be procured, prescribed and issued as per routine NHS practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed with RE (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-overview.html)
- •EEG showing focal sharp waves with normal background (see International League Against Epilepsy Diagnostic Manual at https://www.epilepsydiagnosis.org/syndrome/ects-eeg.html)
- •Aged ≥5 years and <13 years at the time of randomisation
- •Currently untreated with antiepileptic drugs
- •Written informed consent received from person with parental responsibility/legal representative.
- •Family have an email address and regular internet access (for online sleep intervention)
- •Parent and child are to have a good understanding of the English language
排除标准
- •Known contraindication to any of the trial drugs
- •Previously treated for epilepsy with antiepileptic drugs
研究组 & 干预措施
Carbamazepine plus sleep intervention
干预措施: Carbamazepine (Drug)
Carbamazepine plus sleep intervention
干预措施: Parent based sleep (PBS) intervention (Behavioral)
Carbamazepine plus standard care
干预措施: Carbamazepine (Drug)
Levetiracetam plus sleep intervention
干预措施: Levetiracetam (Drug)
Levetiracetam plus sleep intervention
干预措施: Parent based sleep (PBS) intervention (Behavioral)
Levetiracetam plus standard care
干预措施: Levetiracetam (Drug)
No AED plus sleep intervention
干预措施: Parent based sleep (PBS) intervention (Behavioral)
结局指标
主要结局
Time to 6-month seizure remission
时间窗: Up to 48 months
To determine if carbamazepine or levetiracetam are superior to no anti-epileptic drugs
Change from baseline to total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)
时间窗: At 3 months
To determine if a Parent-Based Sleep intervention is superior to standard care
次要结局
- Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control or unacceptable adverse reactions(At 3, 6,12, 24, 36 and 48 months)
- Time taken from randomisation to decision by child, parent or treating physician to be withdrawn from treatment due to inadequate seizure control(At 3, 6,12, 24, 36 and 48 months)
- Time taken from recruitment to decision by child, parent or treating physician to be withdrawn from trial due to unacceptable adverse reactions(At 3, 6,12, 24, 36 and 48 months)
- Total costs measured in Quality-Adjusted Life Years (QALYs)(At 0, 3, 12, 24, 36 and 48 months)
- EQ-5D-5L score change(At 0, 3, 12, 24, 36 and 48 months)
- Time to first seizure based on seizure report(At 3, 6,12, 24, 36 and 48 months)
- Time to 12-month seizure remission based on seizure report(At 3, 6,12, 24, 36 and 48 months)
- Total sleep problem score as measured by the Children's Sleep Habits Questionnaire (CSHQ)(At 12, 24, 36 and 48 months)
- Total score in three chosen assessments delivered by the Cambridge Neuropsychological Test Automated Battery (CANTAB)(At 0, 3, 6,12, 24, 36 and 48 months)
- Score change in Health Related Quality of Life in Children with Epilepsy - Child self-report scale (CHEQOL)(At 0, 12, 24, 36 and 48 months)
- Total score on Strengths and Difficulties Questionnaire (SDQ)(At 0, 12, 24, 36 and 48 months)
- Records of adverse reactions(At 3, 6, 12, 24, 36 and 48 months)
- Score changes in Child Health Utility instrument (CHU9D)(At 0, 3, 12, 24, 36 and 48 months)
- Score changes in EQ-5D-Y(At 0, 3, 12, 24, 36 and 48 months)
- Score changes in Parental Self-Efficacy Measure (PSAM)(At 0, 3, 12, 24, 36 and 48 months)
- Resource Use Questionnaire(At 3, 12, 24, 36 and 48 months)
- Hospital Episode Statistics (HES) Data(48 months, measured for the participant's study duration)
- Patient Level Information and Costing System (PLICS) Data(48 months, measured for the participant's study duration)
- Total sickness related school absences (days)(At 0, 3, 6, 12, 24, 36 and 48 months)