Pure Global AI
ANZCTR12623000855628Not yet recruiting

Effect of cannabidiol on sleep in developmental and epileptic encephalopathies

An evaluation of cannabidiol on sleep and how this relates to epileptic electroencephalogram abnormalities and seizures in adults with Lennox-Gastaut Syndrome and Dravet Syndrome
Alfred HealthNot ApplicableAustralian New Zealand Clinical Trials Registrydiagnostic test
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
Epilepsy
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Alfred Health
Funder
Jazz Pharmaceuticals
Location
Australia
Timeline & enrollment
Phase
Not Applicable
Start date
Aug 21, 2023
End date
Feb 19, 2024
Primary outcome

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.

Summary

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.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000855628
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.