Epilepsy & behavior : E&B · 2026
Caregiver experience of diazepam nasal spray treatment in children aged 2-5 years.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Cramer Joyce A, Segal Eric B, Wheless James W, Peters Jurriaan M, Wolf Steven M, Lopez-Toledano Miguel A, Ngo Leock Y, Carrazana Enrique, Rabinowicz Adrian L
Аннотация
OBJECTIVE: Caregiving for young children with epilepsy (CWE) may have a large impact on families that extends beyond medical care (e.g., psychological conditions and financial concerns). Epilepsy requires long-term treatment, which may include medications both for daily and urgent use. Diazepam nasal spray was used for acute seizure episodes in CWE aged 2-5 years and was evaluated in a Phase 1/2a pharmacokinetics (PK) and safety study. Caregivers provided assessments of changes in their children's responses to treatment and their own experience of treatment usefulness.
METHODS: CWE aged 2-5 y were enrolled in an open-label PK study of diazepam nasal spray with a 180-day open-label safety period and an optional extension period. Data from a seizure severity questionnaire and a caregiver survey at baseline and at safety period follow-up visits (days 30, 90, and 180) were included.
RESULTS: Of 36 enrolled patients, 35 entered, and 31 completed the safety period; 27 entered and completed the optional extension period. Caregivers reported improvement in seizure recovery (61.5% at day 180 vs 38.5% at baseline), indicating it did not take a while for patients to recover after seizures. Similarly, caregivers reported improvements at day 180, compared with baseline, with reductions in caregiver worry (51.9%) and sleep disturbance (57.7%). Caregivers reported much milder and fewer seizure clusters at day 180 vs baseline (50.0%), and family improvement with treatment (69.2%).
CONCLUSION: Caregivers of CWE aged 2-5 years treated with diazepam nasal spray reported improvement in seizure episodes and daily function, reinforcing the value of appropriate treatment.
METHODS: CWE aged 2-5 y were enrolled in an open-label PK study of diazepam nasal spray with a 180-day open-label safety period and an optional extension period. Data from a seizure severity questionnaire and a caregiver survey at baseline and at safety period follow-up visits (days 30, 90, and 180) were included.
RESULTS: Of 36 enrolled patients, 35 entered, and 31 completed the safety period; 27 entered and completed the optional extension period. Caregivers reported improvement in seizure recovery (61.5% at day 180 vs 38.5% at baseline), indicating it did not take a while for patients to recover after seizures. Similarly, caregivers reported improvements at day 180, compared with baseline, with reductions in caregiver worry (51.9%) and sleep disturbance (57.7%). Caregivers reported much milder and fewer seizure clusters at day 180 vs baseline (50.0%), and family improvement with treatment (69.2%).
CONCLUSION: Caregivers of CWE aged 2-5 years treated with diazepam nasal spray reported improvement in seizure episodes and daily function, reinforcing the value of appropriate treatment.