Adults Self-Administering Diazepam Nasal Spray for Seizure Clusters: Results on the Quality of Life in Epilepsy Scale from a Phase 3, Open-Label, Repeat-Dose, Safety Study
Abstract number :
1.293
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825575
Source :
www.aesnet.org
Presentation date :
12/4/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:43 AM
Authors :
Cynthia Guerra, MBA - Neurelis, Inc.; Sunita Misra, MD, PhD - Neurelis, Inc.; Edward Faught, MD - Emory University School of Medicine; Charles Davis, PhD - CSD Biostatistics; Adrian Rabinowicz, MD - Neurelis, Inc.; Enrique Carrazana, MD - Neurelis, Inc.
Rationale: Seizure clusters negatively impact quality of life (QoL). Diazepam nasal spray (Valtoco®) is approved for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. A subgroup of patients in a phase 3 study self-administered diazepam nasal spray: 78% found it easy to use and 48% primarily administered it at the first sign a seizure may be coming. This analysis of the self-administering adults in that study examines results of the Quality of Life in Epilepsy (QOLIE) questionnaire.
Methods: Age- and weight-based doses of diazepam nasal spray were used in this phase 3, long-term, repeat-dose safety study in patients aged 6–65 years. The QOLIE-31-P, a self-reported tool for adults (≥18 years), uses a 4-week recall period and was given at days 0 (baseline), 30, 150, 270, and 365. The overall score is a weighted composite of 7 subscales: Seizure Worry, Overall QoL, Emotional Well-Being, Energy/Fatigue, Cognitive Functioning, Medication Effects, and Social Functioning; scores were analyzed for adults who self-administered diazepam nasal spray, with higher scores indicating better QoL. Descriptive statistics were calculated, and the 2-sided, 2-sample test was used for comparison with non–self-administering adults.
Results: Of 163 treated patients, 27 (16.6%) self-administered diazepam nasal spray (≥18 years, n=25 adults; < 18 years, n=2); 24 (96.0%) completed the last study visit at day 365. Duration of use of diazepam nasal spray was ≥12 months for 96.3% (range, 7.4–39.7 months), with a mean of 2.8 doses per patient per month and 1057 total doses overall.
QOLIE-31-P was assessed for the 25 adult self-administrators and 47 other adults. Overall QOLIE scores for self-administrators were maintained and similar to baseline at all time points (Fig. 1). Among unadjusted subscales, mean scores for seizure worry were higher for self-administrators than scores for other adults by 7.3–16.2 points through day 365; for social functioning, mean scores were higher for self-administrators by 7.0–21.9 points (Fig. 2).
Treatment-emergent adverse events (TEAEs) were reported in 76.0% (19/25) of adult self-administrators, with treatment-related TEAEs reported in 32.0% (8/25). Serious TEAEs were reported in 6 patients; none were treatment related.
Conclusions: The QOLIE scores reported here, especially those for the Seizure Worry and Social Functioning subscales, suggest that the 25 adult patients able to self-administer diazepam nasal spray in this study may have had greater functional status than the non–self-administering adults. The potential for self-administration represents a possible benefit of diazepam nasal spray. QOLIE scores among those who self-administered were maintained from baseline through study end.
Funding: Please list any funding that was received in support of this abstract.: Neurelis, Inc.
Anti-seizure Medications