Licarbazepine

This post hoc analysis examined the reduction in monthly headache days ( MHDs ) by frequency category shifts and associated improvements following eptinezumab treatment.

The DELIVER trial evaluated eptinezumab in adults with migraine for whom 2–4 previous preventive treatments failed. During a 24‐week, double‐blind, placebo‐controlled period followed by a 48‐week extension period, participants received IV eptinezumab 100 mg, 300 mg, or placebo every 12 weeks, with all receiving eptinezumab beginning Week 25 (dose‐blinded). Participants were categorized by MHD frequency: > 14, 8–14, 4 to < 8, 1 to < 4, 0. MHD category shifts were evaluated in the total population and several subgroups (including participants with > 14 baseline MHDs and early ≥ 50% responders). In participants reporting < 8 MHDs after all doses, the associated changes in headache intensity and disease status were evaluated.

Of randomized participants, 88% (782/890) completed the trial. The percentage of participants randomized initially to eptinezumab who reported < 4 MHDs was 23% (138/592) over Weeks 1–12 and 47% (236/498) over Weeks 61–72; 9% reported 0 MHDs after the final dose. Of participants randomized initially to eptinezumab who shifted from ≥ 8 MHDs at baseline to < 8 over Weeks 1–12, 71% (170/241) reported < 8 MHDs for the rest of the trial; of those who shifted from > 14 to < 8 MHDs, 66% (49/74) reported < 8 MHDs for the rest of the trial. Reduction to < 8 MHDs was associated with robust improvements in headache intensity and disease burden.

Eptinezumab was associated with sustained reduction in MHD category, with some achieving headache/migraine freedom in patients with a history of preventive treatments that failed.

ClinicalTrials.gov (identifier: NCT04418765; https://www.clinicaltrials.gov/ct2/show/NCT04418765 ) and EudraCT (identifier: 2019‐004497‐25; https://www.clinicaltrialsregister.eu/ctr‐search/search?query=2019‐004497‐25 )

Epilepsy is a prevalent neurological disorder in children and adolescents aged 0-16 years. Oxcarbazepine is commonly prescribed for its favorable pharmacological profile, yet its metabolism, efficacy, and safety vary widely among individuals. The active metabolite, 10-monohydroxy derivative (MHD), is key to its therapeutic effects, but factors influencing its blood concentration remain unclear. Identifying these determinants is crucial for optimizing personalized treatment. This study analyzed 417 epilepsy patients aged 0-16 years who received oxcarbazepine treatment between January 2023 and October 2024. Steady-state blood concentrations of MHD were measured using immunoassay, and clinical data were collected. Multiple regression models and correlation analyses were applied to determine key factors affecting MHD levels. Daily dose and daily dose per kilogram of body weight showed significant positive correlations with MHD blood concentration (r = 0.606, P < 0.001; r = 0.591, P < 0.001, respectively). Age-related differences were observed, with adolescents exhibiting higher MHD levels than younger children, likely due to differences in metabolic maturation. Gender differences indicated that female patients required higher doses to achieve comparable MHD concentrations as male patients. Renal and hepatic functions (e.g., creatinine and total bilirubin levels) significantly influenced MHD blood concentrations, highlighting the need for careful dose adjustments in patients with physiological impairments. This study provides a comprehensive analysis of MHD blood concentration determinants in pediatric epilepsy patients, emphasizing the importance of personalized treatment approaches. These findings offer a valuable reference for optimizing oxcarbazepine therapy, improving therapeutic outcomes, and minimizing adverse effects in children and adolescents with epilepsy.