Abstracts

Rationale: Despite appropriate antiseizure drugs, seizure clusters can disrupt daily living and health-related quality of life (QoL). Diazepam nasal spray (Valtoco®) is indicated for the acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. This analysis of a long-term safety study assessed scores on the Quality of Life in Epilepsy scale (QOLIE) in adults with epilepsy in subgroups based on frequency of use of diazepam nasal spray to treat seizure clusters.

Methods: A long-term, open-label, repeat-dose safety study of diazepam nasal spray enrolled patients with epilepsy aged 6–65 years. Participants received age- and weight-based doses of diazepam nasal spray for outpatient treatment of seizure clusters. Frequency of treatment was defined as an average of ≥2 vs < 2 doses/month. The QOLIE-31-P, a self-reported tool for adults (≥18 years), uses a 4-week recall period, and was administered on Days 0 (baseline), 30, 150, 270, and 365. The overall score (100-point scale; higher scores signify better QoL) and 7 subscale scores (Seizure Worry, Overall QoL, Emotional Well-Being, Energy/Fatigue, Cognitive Functioning, Medication Effects, Social Functioning) were analyzed in frequent and infrequent users of diazepam nasal spray; in particular, Seizure Worry and Social Functioning were examined because they might be expected to be the most relevant to control of intermittent seizure clusters. Descriptive statistics were calculated, and the 2-sided, 2-sample t test was used for comparison of frequent and infrequent users of diazepam nasal spray.

Results: Of 175 enrolled patients, 163 pediatric (n=78) and adult (n=85) patients were treated; 117 completed the study. The QOLIE-31-P was completed by 74 adults (median age, 33 y [range, 18–65]; female, 59.5%) at one or more timepoints. There were 41 frequent and 33 infrequent users of diazepam nasal spray among QOLIE-31-P respondents (mean [SD] doses per month were 3.2 [1.80] and 1.3 [0.33], respectively). Overall QOLIE-31-P scores were similar between frequent and infrequent users and were slightly higher in both groups during the study (Figure 1). Mean unweighted values for Seizure Worry and Social Function scores for QOLIE-31-P were similar between frequent and infrequent users and rose slightly from baseline (Figure 2). Safety was similar to the full study, with 23.0% reporting treatment-related treatment-emergent adverse events (18.4% in full study); none were serious or led to discontinuation.

Conclusions: In both frequent and infrequent groups, QOLIE-31-P scores were maintained, increased slightly over 365 days with diazepam nasal spray available as a rescue treatment for seizure clusters. Patients with less frequent seizure clusters (about 1.3 per 28-day recall period) had higher baseline overall QOLIE scores; however, overall change in overall scores was higher in the frequent usage group.

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