Abstract Details

Title Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study

Topic Headache

Presentation(s) P13 - Poster Session 13 (8:00 AM-9:00 AM)

Poster/Presentation
Number 2-003

Objective To assess patients’ impression and satisfaction with STS101 in a long-term, open-label safety study.

Background The ASCEND trial assessed the safety and tolerability of STS101 5.2 mg (dihydroergotamine nasal powder) in the acute treatment of migraine with/without aura over 12 months. STS101 is a novel investigational product for rapid and easy nasal delivery.

Design/Methods ASCEND (NCT04406649) is a multi-center, multiple-dose, open-label study in 344 adults (18-65 years) with migraine. Participants self-administered STS101 for ≤2 doses/24 hours and ≤12 doses/month for 12 months. Patient global impression, ease-of-use impression, patient likelihood of use, and comparison of study medication with previously used migraine medication were collected at 3-,6-, and 12-month timepoints and analyzed in the modified intent-to-treat population. All questions were assessed using a 5-point verbal Likert scale.

Results

At 3 and 12 months, 90.7% (262/289) and 88.5% (108/122) of subjects agreed that STS101 was easy/very easy to use. In comparison to their usual medication, most participants at 3 and 12 months agreed/strongly agreed that they returned to normal faster (66.2% [188/284]; 64.7% [183/283]) and that STS101 kept their migraine from returning (62.2% [176/283]; 66.7% [80/120]), more consistently treated migraine (70.4% [200/284]; 73.6% [89/121]), and worked faster (64.7% [183/283]; 70.0% [84/120]. Subjects indicated they would be likely/very likely to use STS101 if available (75.8% [219/289]; 77.0% [94/122]). Over 80% of subjects reported a good/very good impression of STS101 at each time point (3 months, 83.8% [243/290]; 12 months, 91.0% [111/122]).

Conclusions Subject impression data through 12 months suggest that STS101 was perceived very favorably by subjects on multiple measures, including in comparison to their usual migraine medications.

Authors/Disclosures
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology) PRESENTER	Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
Larry "LC" Charleston IV, MD, MSc, FAHS, FANA, FAAN (A NeuRaye Of Sunshine Publishing, LLC)	Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma Pharmaceuticals. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LinPharma. Dr. Charleston has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Haleon. Dr. Charleston has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. The institution of Dr. Charleston has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. Dr. Charleston has or had stock in Mi-Helper Inc..Dr. Charleston has a non-compensated relationship as a Associate Editor with Headache Journal: The Journal of Head and Face Pain that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Board Member with Clinical Neurological Society of America that is relevant to AAN interests or activities. Dr. Charleston has a non-compensated relationship as a Chair, EDI Advisory Committee (Non-voting Board Member) with American Headache Society that is relevant to AAN interests or activities.
Detlef Albrecht	Detlef Albrecht has received personal compensation for serving as an employee of Satsuma. Detlef Albrecht has stock in Satsuma.

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