Effect of cannabidiol on sleep in developmental and epileptic encephalopathies
- Disease/Condition
- Epilepsy
- Study type
- Observational
- Intervention type
- diagnostic test
- Primary sponsor
- Alfred Health
- Funder
- Jazz Pharmaceuticals
- Location
- Australia
- Phase
- Not Applicable
- Start date
- Aug 21, 2023
- End date
- Feb 19, 2024
Any change in sleep quality in patients with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) taking cannabidiol will be assessed by a change in cortical arousal index.
This is a multi-centre, prospective, cohort study to evaluate epileptic encephalogram abnormalities and seizures in relation to sleep measures using polysomnography in patients diagnosed with an epileptic encephalopathy (Dravet syndrome and LGS) during video-EEG monitoring admission and are undergoing treatment with cannabidiol (EPIDYOLEX) as part of their routine clinical care. A total of 26 patients will be recruited from The Alfred and The Austin hospitals who are newly prescribed with EPIDYOLEX but have not yet commenced. The study will consist of a 4-week baseline period prior to drug initiation, during which time participants will keep a seizure diary and undergo actigraphy (GENEActiv accelerometer wristwatch) measurements. Participants will subsequently undergo two hospital admissions consisting of 24-hour EEG and polysomnography assessments at baseline, and the end of the study (16-weeks following drug initiation), respectively; actigraphy will be measured throughout the study period. All medications or interventions for epilepsy will remain unchanged the 4-weeks during the screening period and throughout the study period.
- Registry
- Australian New Zealand Clinical Trials Registry
- Trial ID
- ANZCTR12623000855628
- Type
- Non-Device Trial
Access comprehensive clinical trial information for ANZCTR12623000855628 through Pure Global AI's free database. This Not Applicable trial is sponsored by Alfred Health and is currently Not yet recruiting. The study focuses on Epilepsy.
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