Effect of cannabidiol on sleep in developmental and epileptic encephalopathies
- Conditions
- EpilepsyNeurological - Epilepsy
- Registration Number
- ACTRN12623000855628
- Lead Sponsor
- Alfred Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 26
Participants will be eligible to be included in the study if all the following criteria apply:
•Aged 18 to 60 years;
•Diagnosis of Dravet syndrome or Lennox-Gastaut syndrome and prescribed, but have not yet commenced EPIDYOLEX as part of their routine clinical care by their neurologist;
•Stable epilepsy treatment (pharmacotherapy treatment, ketogenic diet, vagal nerve stimulation or deep brain stimulation) for at least 4 weeks prior to treatment initiation; and
•Written informed consent obtained from the participant prior to any study-related procedures.
Participants are excluded from the study if any of the following criteria apply:
•Current treatment with cannabis-based products;
•Unstable hepatic or renal disease;
•Epilepsy surgery, or vagal nerve stimulation/deep brain stimulation implantation in the past 6-months; or
•Patients treated with continuous positive airway pressure (CPAP) .
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method