Interim Analysis of Subject Impression Data for STS101 From the Phase 3 Open-Label ASCEND Study
Jessica Ailani1, Larry Charleston2, Detlef Albrecht3
1Medstar Georgetown Neurology, 2Michigan State University College of Human Medicine, 3Satsuma
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.