CANABID-LD (V1)

  • Research type

    Research Study

  • Full title

    CANnabidiol impact on challenging behaviour in Adults with Intellectual Disability with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex (CANABID-LD): a prospective observational cohort study.

  • IRAS ID

    330775

  • Contact name

    John Martin

  • Contact email

    plymouth.sponsor@plymouth.ac.uk

  • Duration of Study in the UK

    1 years, 5 months, 26 days

  • Research summary

    Intellectual disability (ID) affects a person’s ability to learn, reason, and manage daily tasks; ID is common in people with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS) and tuberous sclerosis complex (TSC), which are forms of epilepsy. Challenging behaviour refers to actions that are extreme or difficult to manage, potentially putting the person or others at risk and making it difficult to take part in everyday activities. People with ID and epilepsy are more likely to show challenging behaviours. These behavioural issues are common in DS, LGS and TSC and can negatively impact a person’s quality of life. There are currently no highly effective medications to help manage challenging behaviours, so there is a need for better treatment options. Cannabidiol (Epidyolex) is an approved medication used to help control seizures in people with LGS, DS or TSC. Since many people with LGS, DS or TSC are prescribed Epidyolex for seizure management, researchers have a good opportunity to study whether it also helps improve challenging behaviours. CANABID-LD is an observational study, where participants with DS, LGS and TSC who are going to be prospectively prescribed cannabidiol are followed up at three timepoint over 6-months (baseline, 3-months and 6-months). Usual care will not change, and participants will not have to attend additional clinic visits. Data will be collected remotely, with support from the primary caregiver, relating to challenging behaviours, quality of life and seizure frequency. The study is funded by Jazz Pharmaceuticals and will recruit 60 participants across approximately 10 sites in the United Kingdom over a 6-month period.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    25/YH/0142

  • Date of REC Opinion

    29 Aug 2025

  • REC opinion

    Further Information Favourable Opinion