Abstracts

Rationale: Patients with seizure clusters may experience reduced quality of life (QoL) and could benefit from a rescue treatment that can be easily administered in any setting. Diazepam nasal spray (Valtoco®) is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. A long-term safety study of diazepam nasal spray examined Quality of Life in Epilepsy (QOLIE) and treatment satisfaction among patients and caregivers.

Methods: Patients (6-65 years) in a long-term, open-label safety study of diazepam nasal spray used 5-, 10-, 15- or 20-mg doses (based on age and weight) to treat seizure clusters. QOLIE-31-P and QOLIE-48 are epilepsy-specific instruments to assess health-related QoL in adults (≥18 years) and adolescents (11–17 years), respectively. Total scores, on a 100-point scale, are a weighted composite of 7 (QOLIE-31-P) or 8 (QOLIE-48) 100-point unweighted subscales. Higher scores indicate better QoL. Patients aged ≥11 years completed the age-appropriate assessment at baseline (Day 0) and Days 30, 150, 270 and 365. In addition, near study end or after study completion/discontinuation, patient and caregiver pairs completed surveys assessing use of rescue medications and comfort with/ease of using diazepam nasal spray. Descriptive statistics were calculated on QOLIE and survey data for the subset of patients with QOLIE baseline data (Day 0 or 30), survey data, and a caregiver-completed survey.

Results: Of 163 treated patients, 5 adults and 14 adolescents and their caregivers provided data for the QOLIE and the survey analyses. Mean total QOLIE-31-P score was stable across time with a numerical improvement from baseline in mean Seizure Worry subscore (Figure 1). Mean total QOLIE-48 score also remained stable across time with no consistent trends in subscale scores (Figure 2). Survey responses on comfort carrying diazepam nasal spray outside the home showed most patients and caregivers were extremely or very comfortable (84.2% and 88.9%, respectively); responses on comfort doing activities outside the home while having diazepam nasal spray available showed most patients and caregivers were extremely or very comfortable (94.7% and 88.9%, respectively).

In the study overall, safety of diazepam nasal spray was similar to rectal diazepam; no treatment-related adverse events were considered serious or led to discontinuation.

Conclusions: In this small subset analysis from a long-term safety study, QOLIE scores generally remained stable with a slight increase in Seizure Worry scores in the adults. Based on survey data, patients and caregivers had a high degree of comfort carrying diazepam nasal spray and doing daily activities outside the home. QOLIE assessments may be less sensitive for measuring change with an intermittent rescue therapy compared with a survey geared toward assessing comfort with intermittent seizure treatment. Both types of measures suggest diazepam nasal spray availability may decrease concern about seizure occurrence.

Funding: Please list any funding that was received in support of this abstract.: Neurelis, Inc.