Epilepsy Nervous System Diseases Rolandic epilepsy
Conditions
Interventions
Written informed consent (and assent), Participants will be given ample time to review the patient information sheet. Discussion of objectives, risks and inconveniences of the trial and the conditions
Children’s Sleep Habits Questionnaire (CSHQ), The parent/primary carer will complete this questionnaire on paper when they attend clinic.
Learning measured by standardised learning measure - CANTAB, The child will complete this questionnaire/puzzle on an iPad when they attend clinic.
Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL questionnaire), Both the parent/primary carer and the child (if >8 years) will complete this questionnaire on paper when they
Strengths and Difficulties Questionnaire (SDQ), The parent/primary carer will complete this questionnaire on paper when they attend clinic.
Health Utility Measures – adult (EQ-5D-5L), The parent/primary carer will complete this questionnaire on paper when they attend clinic.
Actigraphy, A purposeful sample of 10 dyads (child and primary carer) from each of the 6 final trial subgroups (120 subjects in total) will both wear the watches for 1 week at baseline, 3 and 12 month
Qualitative Interviews (for those who consent), Interviews will be conducted by the research team at Edge Hill University and they will either be face-t
Sponsors
King's College London
King’s College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children diagnosed with RE 2. EEG showing focal sharp waves with normal background 3. Aged >=5 years and <13 years at the time of randomisation 4. Currently untreated with antiepileptic drugs 5. Written informed consent received from person with parental responsibility/legal representative. 6. Family have a valid email address and regular internet access (for online sleep intervention) 7. Parent and child are to have a good understanding of the English language. Parent-child dyads meeting the trial criteria and the following characteristics will be eligible for inclusion in the qualitative sub-study: 1 Ability of parent and child to speak conversational English 2 Additional consent to main trial: Consent of parent to participate and for their child to participate
Exclusion criteria
Exclusion criteria: 1. Known contraindication to any of the trial drugs 2. Previously treated for epilepsy with antiepileptic drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine if carbamazepine or levetiracetam are superior to no AED with respect to time to 6- month seizure remission measured using time to 6-month seizure remission based on seizure report at 3, 6,12 months and annually thereafter. 2. To determine if a PBS intervention is superior to standard care with respect to 3-month sleep problem frequency measured by CSHQ at baseline and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare time to treatment failure due to inadequate seizure control or unacceptable adverse reactions measured using 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 months and annually thereafter 2. To compare time to treatment failure due to inadequate seizure control measured using 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 months and annually thereafter 3. To compare time to treatment failure due to unacceptable adverse reactions measured using 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 months and annually thereafter 4. To compare time to first seizure measured using time to first seizure based on seizure report at 3,6,12 months and annually thereafter 5. To compare time to 12-month remission from seizures measured using time to 12-month seizure remission based on seizure report at 3, 6, 12 months and annually thereafter 6. To determine if a PBS intervention is superior to standard care measured using total sleep problem score as measured by the CSHQ at 12 months and annually thereafter 7. To compare measures of cognition across the different treatment groups measured using total score in three chosen assessments delivered by CANTAB iPad Neuropsychological battery at baseline, 3 and 12 months and annually thereafter 8. To compare Health Related Quality of Life across the different treatment groups measured using CHEQOL score change at baseline and 12 months and annually thereafter 9. To compare measures of children’s behaviour across the different treatment groups m | — |
Countries
United Kingdom
Outcome results
None listed