Exploring cannabidiol’s impact on behaviour in adults with intellectual disabilities and epilepsy (CANABID-LD)
| ISRCTN | ISRCTN10870412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10870412 |
| Integrated Research Application System (IRAS) | 330775 |
| Central Portfolio Management System (CPMS) | 57056 |
| Grant Code | 2023-IST-300020 |
| Sponsor | University of Plymouth |
| Funder | Jazz Pharmaceuticals |
- Submission date
- 03/11/2025
- Registration date
- 02/02/2026
- Last edited
- 02/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Some people with epilepsy also have intellectual disability (ID), which can affect how they learn, communicate, and manage everyday tasks. Certain types of epilepsy—Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC)—often come with both ID and challenging behaviours. These behaviours can be difficult to manage and may affect the person’s safety and quality of life. There aren’t many effective medicines to help with these behaviours. Cannabidiol (Epidyolex) is a medicine already approved to help control seizures in people with DS, LGS or TSC. This study aims to find out whether Epidyolex might also help reduce challenging behaviours and improve quality of life.
Who can participate?
People aged 16 or older who have a confirmed diagnosis of DS, LGS or TSC, along with an intellectual disability, and who are about to start taking Epidyolex for seizures. Participants must be under the care of specialist NHS services and have a caregiver who can help with the study. Consent will be given either by the participant or by someone who knows them well and can speak on their behalf.
What does the study involve?
This is an observational study, which means participants will not be asked to take any extra medication or change their usual care. The study will follow participants over six months, with check-ins at the start, after three months, and after six months. All data will be collected remotely, with help from the participant’s caregiver. Researchers will look at changes in behaviour, seizure frequency, and quality of life.
What are the possible benefits and risks of participating?
There may be no direct benefit, but the study could help improve future care and treatment options for people with epilepsy and ID. Because the study does not involve any changes to treatment or extra clinic visits, risks are minimal.
Where is the study run from?
University of Plymouth (UK)
When is the study starting and how long is it expected to run for?
October 2025 to January 2027
Who is funding the study?
Jazz Pharmaceuticals (UK)
Who is the main contact?
canabid.penctu@plymouth.ac.uk
Contact information
Public, Scientific, Principal investigator
Peninsula Clinical Trials Unit, Faculty of Health, University of Plymouth, N16, ITTC Building 1, Plymouth Science Park
Plymouth
PL6 8BX
United Kingdom
 ORCID ID |
0009-0008-8199-5447 |
|---|---|
| Phone | +44 1752 439831 |
| canabid.penctu@plymouth.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Scientific 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 |
| Study acronym | CANABID-LD |
| Study objectives | Primary objective: To determine if cannabidiol affects challenging behaviours in patients with ID and epilepsy, determined by changes to the ABC-2 Irritability subscale score between baseline and 180 days post initiation of treatment. Secondary objectives: 1. To determine if cannabidiol affects other behavioural, clinical and psychological outcomes associated with cannabidiol prescribing at 90 days and 180 days post-treatment initiation. 2. To explore the association between cannabidiol dose and change in challenging behaviour. 3. To determine any changes in seizure type/frequency at 90 days and 180 days post-treatment initiation. 4. To test methods to economically evaluate the provision of cannabidiol and its impact on quality of life. 5. To explore differences in changes to challenging behaviour between those who meet the threshold for moderate to severe challenging behaviour at baseline (Group A) and those who do not meet threshold for moderate to severe challenging behaviour - i.e., no challenging behaviour or mild challenging behaviour at baseline (Group B). 6. To gain a deeper understanding of participant/primary caregiver/clinician’s experience of cannabidiol on challenging behaviours and seizures, including treatment acceptability (WP2). |
| Ethics approval(s) |
Approved 29/08/2025, Yorkshire & The Humber - Leeds East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8029; leedseast.rec@hra.nhs.uk), ref: 25/YH/0142 |
| Health condition(s) or problem(s) studied | Adults with Intellectual Disability with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex |
| Intervention | CANABID-LD is a prospective observational cohort study, with an embedded qualitative component, to examine the impact of cannabidiol on challenging behaviour, seizure type/frequency and quality of life when prescribed for clinical indicated reason of seizure management in people with LGS/DS/TSC. The overall protocol aim is to examine the relationship of prescribed cannabidiol for pharmaco-resistant seizures on challenging behaviours, seizure frequency and quality of life, among adults with LGS, DS or TSC with co-occurring ID. This study is separated into two Work Packages (WP1 and WP2). WP1 refers to the observational cohort study. 60 participants will be recruited who are going to prospectively commence treatment with Epidyolex. Data will be collected at three time points over a 6-month period (baseline, 3-month post-treatment initiation and 6-months post-treatment initiation). Consent and baseline data collection may take place face-to-face, if a routine clinic visit is scheduled, or remotely. Baseline data, including diagnosis, ID classification, demographics, medications and co-morbidities, will be collected using routine medical record information. In addition, three questionnaires/scales will be administered to the participant's primary caregiver with support of the researcher/clinician (EQ-5D-5L, ABC-2 and HONOS-ID) and data will be asked about the participant's seizure type/frequency. The primary caregiver will be contacted via telephone again at the 3-month and 6-month, where the same questionnaires/scales will be administered (EQ-5D-5L, ABC-2 and HONOS-ID) and they will be asked about any medication changes, seizure type/frequency and any key events that may have significantly impacted behaviour. The caregiver will be provided with copies of the questionnaires and a seizure and key event record to support accurate data collection. WP2 is an embedded qualitative component. 15 primary caregivers of participants involved in WP1 will be invited to take part in a 60 minutes semi-structured interview to discuss the participant's experience with Epidyolex. The primary caregiver will have the option on the consultee declaration form to indicate that they are happy to be contacted about the additional interview study. Interviews will take place at the end of the participant's time on the study (6-months after treatment initiation) remotely, via video-conferencing or Microsoft Teams. 10 clinicians will also be interviewed, one from each site, who have been involved in the study and have experience with Epidyolex prescribing for DS, LGS and TSC patients. These will also take place via video-conferencing or telephone call in a semi-structured format. This is to obtain information about the clinician experience with Epidyolex. |
| Intervention type | Other |
| Primary outcome measure(s) |
Aberrant Behaviour Checklist-Second edition (ABC-2) Irritability subscale at baseline, 180 days |
| Key secondary outcome measure(s) |
1. Health status is measured using the Health of the Nation Outcome Scale for People with Intellectual Difficulties (HONOS-ID) at baseline, 90 days, and 180 days |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. ≥ 16 years of age at the time of enrolment. 2. Confirmed clinical diagnosis of Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS), or Tuberous Sclerosis Complex (TSC). 3. Confirmed clinical diagnosis of an Intellectual Disability (ID). 4. Patient meets the clinical criteria to be prescribed regulatory approved cannabidiol (Epidyolex) for seizure management, as per clinician judgment. 5. Patient is scheduled to start, but has not yet commenced, cannabidiol treatment. 6. Participant has the capacity to be able to provide consent for themselves, or a personal/professional consultee is able to provide an opinion on the views and feelings of the participant. 7. Participant has a primary caregiver who is willing and able to complete caregiver-reported outcome measures. 8. Willing and able to complete all scheduled follow-ups. |
| Key exclusion criteria | Patients previously or already on prescribed regulatory approved cannabidiol. |
| Date of first enrolment | 10/10/2025 |
| Date of final enrolment | 30/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Tonna Uchaf
Tonna
Neath
SA11 3LX
Wales
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Beckett Street
Leeds
LS9 7TF
England
London
NW1 2PG
England
Pond Street
London
NW3 2QG
England
Holt Street
Birmingham Science Park, Aston
Birmingham
B7 4BN
England
Infirmary Square
Leicester
LE1 5WW
England
Fazakerley
Liverpool
L9 7LJ
England
Bath
BA1 3NG
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (PEARL, University of Plymouth open access research repository. Fully anonymised data will be available at the end of the study for a minimum of ten years. Participant’s informed consent is received in relating to data processing and storage arrangements). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.2 | 22/10/2025 | 24/11/2025 | No | No |
Additional files
- 48364 CB001_CANABID-LD Protocol_V1.2_22OCT2025.pdf
- Protocol file
Editorial Notes
03/11/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
