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Abstract Details

Treatment Satisfaction, Anxiety Level, and Confidence About Traveling With Midazolam Nasal Spray in Patients With Seizure Clusters: Phase III, Open-Label Extension Trial
Epilepsy/Clinical Neurophysiology (EEG)
Epilepsy/Clinical Neurophysiology (EEG) Posters (7:00 AM-5:00 PM)
128
Assess treatment satisfaction, anxiety level, and confidence about traveling with midazolam nasal spray (MDZ-NS) after repeated intermittent use in outpatient setting.

Medication adherence and, potentially, improved outcomes are associated with treatment satisfaction.

ARTEMIS-2/P261-402 (NCT01529034) was a Phase III, open-label extension trial in patients (≥12 years) with seizure clusters (SCs). Caregivers administered MDZ-NS 5 mg when patients experienced a SC; a second dose could be given if seizures did not end within 10 min or recurred within 6 h post MDZ-NS administration. Patient satisfaction with MDZ-NS was assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), and patient and caregiver perceptions of how having access to MDZ-NS might impact their lives with Intranasal Therapy Impact Questionnaire (ITIQ). Patients and caregivers completed questionnaires at each visit (after one treated SC after Visit [V]1 and V2, and after two treated SCs thereafter). Analyses were exploratory.

161/175 enrolled patients (92.0%) were evaluable. All TSQM scales showed improvement from Baseline at Last Visit (mean change 4.3–8.8; p<0.05 to <0.001). Mean change from Baseline showed a tendency to improve at V1–V10 for all TSQM scales except side-effects; improvement generally increased over repeated MDZ-NS use for all scales. Mean change in anxiety level since receiving MDZ-NS (ITIQ) improved from 2.5 (standard deviation 2.5) (V1) to 3.5 (2.7) (Last Visit) in patients and from 2.6 (2.5) to 3.6 (2.7) in caregivers, and generally improved over repeated MDZ-NS use. Proportions of patients and caregivers who answered ‘strongly agree’ or ‘agree’ for confidence about traveling with an intranasal spray was ≥79% throughout and rose from V1–V10.

Patients perceived MDZ-NS as a favorable therapy: perceived effectiveness, side-effects, convenience, and global satisfaction showed improvement from Baseline. This is supported by improvement in anxiety level and consistently high confidence about traveling with MDZ-NS in patients and caregivers over repeated intermittent use.

Authors/Disclosures
Toufic Fakhoury, MD (St. Joseph Neurological Assicates)
PRESENTER
Dr. Fakhoury has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB pharma. Dr. Fakhoury has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai . Dr. Fakhoury has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aquestive therapeutics. Dr. Fakhoury has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Fakhoury has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Fakhoury has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. The institution of Dr. Fakhoury has received research support from Xenon. The institution of Dr. Fakhoury has received research support from Takeda.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Tze-Chiang Meng Tze-Chiang Meng has received personal compensation for serving as an employee of Proximagen, LLC. An immediate family member of Tze-Chiang Meng has a non-compensated relationship as a Stockholder with Abbott Laboratories that is relevant to Âé¶¹´«Ã½Ó³»­ interests or activities. An immediate family member of Tze-Chiang Meng has a non-compensated relationship as a Stockholder with Johnson & Johnson that is relevant to Âé¶¹´«Ã½Ó³»­ interests or activities. An immediate family member of Tze-Chiang Meng has a non-compensated relationship as a Stockholder with Medtronic that is relevant to Âé¶¹´«Ã½Ó³»­ interests or activities. Tze-Chiang Meng has a non-compensated relationship as a Stockholder with 3M that is relevant to Âé¶¹´«Ã½Ó³»­ interests or activities.
Peter Van Ess Peter Van Ess has received personal compensation for serving as an employee of Proximagen.
No disclosure on file