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Abstract Details

Examining the Patient Experience With Diazepam Nasal Spray for Seizure Clusters: Patient-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
130
Patient responses to a survey from a phase 3 safety study of diazepam nasal spray were analyzed.
Ideal rescue treatments for patients with epilepsy should be easy for nonmedical individuals to use; therefore, it is important to assess user perceptions of these treatments. Diazepam nasal spray (Valtoco®) is indicated for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years. 
Patients and caregivers were trained to administer age- and weight-based doses of 5, 10, 15, or 20 mg. A survey was given to patients and caregivers at study end and was mailed to those who had completed or discontinued the study. Data were collected on comfort using diazepam nasal spray outside the home, timing of administration, and comfort of use compared with rectal diazepam. Safety was assessed.

Of 175 subjects enrolled at interim cutoff, 158 received diazepam nasal spray; 67 responded to the survey (66 with safety data). Thirty-two (48%) reported past use of rectal diazepam.

Most patients were very comfortable doing activities outside the home if they had diazepam nasal spray available (78.8%); 87.9% carried diazepam nasal spray outside the home, and 84.5% were very or extremely comfortable carrying diazepam nasal spray. Diazepam nasal spray was primarily administered at the first signs of a seizure (46.2%). Compared with diazepam nasal spray, 86.7% were not at all comfortable having rectal diazepam publicly administered.

Fifty-one patients (77.3%) had a treatment-emergent adverse event (TEAE). Seventeen (25.8%) had a serious TEAE; none were treatment related. Four mild and 1 moderate report of nasal discomfort were assessed as treatment related.
In this survey, patients were comfortable with diazepam nasal spray outside the home and were more comfortable being treated in public than with rectal diazepam. Safety was consistent with diazepam.
Authors/Disclosures
Patricia E. Penovich, MD, FÂ鶹´«Ã½Ó³»­
PRESENTER 		Dr. Penovich has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engage therapeutics. Dr. Penovich has received personal compensation in the range of $0-$499 for serving as a Consultant for LVIS. Dr. Penovich has received personal compensation in the range of $0-$499 for serving as a Consultant for Monteris. Dr. Penovich has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SK Therapeutics. Dr. Penovich has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurelis. Dr. Penovich has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Greenwich. Dr. Penovich has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for SK Biosciences. Dr. Penovich has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelis. Dr. Penovich has a non-compensated relationship as a Comittee Member with American Epilepsy Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
James W. Wheless, MD, FAAP, FACP, FAES, FCNS, FÂ鶹´«Ã½Ó³»­ Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Azurity. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoke. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
No disclosure on file
Cynthia Guerra Cynthia Guerra has received personal compensation for serving as an employee of Neurelis, Inc. Cynthia Guerra has received stock or an ownership interest from Neurelis Inc.
Dave F. Cook No disclosure on file
Enrique Carrazana (Neurelis, Inc.) Enrique Carrazana has received personal compensation for serving as an employee of Neurelis. Enrique Carrazana has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Hawaii-Biotech, CND Life Sciences, Apex Labs. Enrique Carrazana has stock in Neurelis, CND, Apex.
No disclosure on file