This study is being conducted to evaluate the effects of GWP42003-P on cognition in pediatric participants, aged 3 to 10 years, with Lennox-Gastaut Syndrome (LGS).
This trial is a 30-week (4-week baseline period; 26-week treatment period) open-label exploratory investigation of the effects of GWP42003-P on cognitive abilities in participants with LGS who reside in the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
oral solution of 100 milligrams per milliliter (mg/mL) cannabidiol (CBD)
Change from Baseline to end of treatment (Day 181 [Visit 5]) in processing speed on the National Institutes of Health Toolbox Cognition Battery (NIHTCB)
Time frame: Baseline; Day 181
Change from Baseline to Day 91 (Visit 4) in processing speed on the NIHTCB
Time frame: Baseline; Day 91
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in executive function and attention on the NIHTCB
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in episodic memory on the NIHTCB
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in language on the NIHTCB
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in the NIHTCB Childhood Composite Score
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) or BRIEF, Preschool (BRIEF-P) for participants aged 5 years or younger
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in weekly seizure frequency
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in behavior using the Aberrant Behavior Checklist, Second Edition Community Forms (ABC-2-3)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in sleep characteristics using the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 181 (end of treatment; Visit 5) in quality of life using the Pediatric Quality of Life Inventory (PEDS-QL4)
Time frame: Baseline; Day 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in generic health status using the EQ-5D-Y Proxy Version 1
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in the Caregiver Global Impression of Change (CGIC) score
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in Patient-Reported Outcomes Measurement Information System (PROMIS®) - Parent Proxy Short Form Anxiety and Depression Subscales
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in Parenting Stress Index, Fourth Edition (PSI-4)
Time frame: Baseline; Days 91 and 181
Change from Baseline to Day 181 (end of treatment; Visit 5) in the participant's ability to perform day-to-day tasks
Time frame: Baseline; Day181
Change from Baseline to Day 91 (Visit 4) and Day 181 (end of treatment; Visit 5) in the Physician Global Impression of Change (PGIC) score
Time frame: Baseline; Days 91 and 181
Number of participants with the indicated type of adverse event
Time frame: up to Day 219
Number of participants with clinically significant changes in laboratory parameter values
Time frame: Baseline; up to Day 191
Number of participants with clinically significant changes in physical examination findings
Time frame: Baseline; up to Day 191
Number of participants with clinically significant changes in vital sign values
Time frame: Baseline; up to Day 191