Caregiver-reported non-seizure and seizure outcomes with cannabidiol and clobazam in patients aged ≥2 years with Lennox-Gastaut syndrome or Dravet syndrome: A subgroup analysis of the BECOME survey

PURPOSE: This subgroup analysis of the BECOME (BEhavior, COgnition, and More with Epidiolex®) survey analyzed caregiver-reported seizure and non-seizure outcomes, including changes in caregiver burden, following cannabidiol (CBD) treatment in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) aged ≥2 years taking concomitant clobazam, aligned with the European Medicines Agency indication. METHODS: US-based caregivers of patients with LGS/DS receiving CBD (Epidiolex®, 100 mg/mL oral solution) for ≥3 months rated patient outcome changes, comparing the previous month with pre-CBD initiation. Multiple-choice and rank-order questions with symmetrical 3-, 5-, or 7-point scales ranging from worsening to improvement were used. RESULTS: Patients (N = 243; 76 % LGS, 24 % DS; 52 % male; mean [range] age 15 [2-53] years) took a median of 14 mg/kg/day CBD and a median of four other antiseizure medications, including clobazam. Caregivers reported improvements in seizure frequency (87 %), severity (81 %), and weekly seizure-free days (net improvement across seizure types 68 %). Caregivers noted improvements in ≥1 question for non-seizure domains (net data across questions within each domain): alertness, cognition, and executive function (84 %); language and communication in non-verbal (81 %) and verbal (76 %) patients; emotional and social functioning (79 %); daily activities (56 %); physical functioning (44 %); and sleep (56 %). Additionally, 4-26 % of caregivers (net) reported worsening in ≥1 question in any domain. Overall, 94 % of caregivers planned to continue CBD treatment. CONCLUSIONS: Consistent with the overall BECOME survey, most caregivers of patients with LGS/DS aged ≥2 years taking concomitant clobazam reported improvements in seizure and non-seizure outcomes since initiating CBD treatment.