Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE)
- Conditions
- Rolandic EpilepsyMedDRA version: 21.1Level: PTClassification code 10070530Term: Benign rolandic epilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-003893-29-GB
- Lead Sponsor
- King's College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 330
a. Children diagnosed with RE
b. EEG showing focal sharp waves with normal background
c. Aged =5 years and <13 years at the time of randomisation
d. Currently untreated with antiepileptic drugs
e. Written informed consent received from person with parental responsibility/legal representative.
f. Family have a valid email address and regular internet access (for online sleep intervention)
g. 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:
h. Ability of parent and child to speak conversational English
i. Additional consent to main trial: Consent of parent to participate and for their child to participate.
Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
a. Known contraindication to any of the trial drugs
b. Previously treated for epilepsy with antiepileptic drugs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method