Adults with Intellectual Disability with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex Nervous System Diseases
Conditions
Interventions
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 lif
Sponsors
University of Plymouth
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: Patients previously or already on prescribed regulatory approved cannabidiol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aberrant Behaviour Checklist-Second edition (ABC-2) Irritability subscale at baseline, 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 2. Clinical global impression is measured using the Clinical Global Impression (CGI) scale at 180 days or routine follow-up visit 3. Aberrant behavior is measured using the Aberrant Behavior Checklist-2 (ABC-2) at baseline, 90 days, and 180 days 4. Cannabidiol daily dose (mg/kg/day) is measured using treatment records at baseline, 90 days, and 180 days 5. Seizure type and frequency are measured using seizure diaries or clinical records at baseline, 90 days, and 180 days 6. Health-related quality of life is measured using the EQ-5D-5L Proxy Version 2 questionnaire at baseline, 90 days, and 180 days 7. Resource utilization is measured using the resource use questionnaire at baseline, 90 days, and 180 days 8. Semi-structured qualitative data on participant experience is measured using interviews at 180 days after treatment initiation | — |
Countries
England, United Kingdom
Contacts
Public ContactAbbey Tufft
Outcome results
None listed