Mean total Quality-of-Life scores in patients reporting data at one or more timepoints demonstrated a clinically important improvement during the 12-month study
Reduced seizure worry and improved social functioning were the most significant findings
July 20, 2022— Neurelis, Inc., issued a press release, which is summarized as follows:
Seventy-two of 85 adult patients with seizure clusters who were enrolled in the long-term, Phase 3, open-label clinical trial of VALTOCO (diazepam nasal spray) reported stable or increased Quality of Life (QoL) during the study, according to recent findings published online in the leading journal, Epilepsy & Behavior.
“These findings indicate that if we can reduce the number of seizure clusters with acute, rapid therapies, we potentially can have an impact on both seizure worry and social functioning.” said Adrian Rabinowicz, MD, SVP Clinical Development and Medical Affairs.
Until now, limited research has been conducted to assess QoL as a potential secondary endpoint in patients with seizure clusters. The 12-month study of diazepam nasal spray enrolled patients 6-to-65 years with seizure clusters. Adults ≥18 years completed the Quality of Life in Epilepsy (QOLIE)-31-P at baseline (day 0) and days 30, 150, 270, and 365. Participants answered questions about their health and daily activities, and responses were assigned numeric values (1-100). Higher scores indicated better QoL.
QoL measures included seizure worry, overall QoL, emotional wellbeing, energy/fatigue, cognitive functioning, medication effects, and social functioning.