Study participant impression of use and satisfaction with STS101 (dihydroergotamine nasal powder): Results from the open-label ASCEND acute migraine study.

OBJECTIVE/

backgroundThis study was undertaken to assess participants' impression of use and satisfaction with STS101 in a long-term, open-label safety study. The ASCEND study assessed the safety and tolerability of STS101, an investigational drug-device combination of 5.2 mg dihydroergotamine in a single-use nasal delivery device for the acute treatment of migraine with/without aura, across 12 months.

methodsASCEND (NCT04406649) was an open-label, single-arm, prospective interventional study in adults (18-65 years) with history of migraine from September 2020 to January 2023. Participants could self-administer STS101 for ≤2 doses within 24 h to treat a single migraine attack and ≤12 doses/month. Data on 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. Participants' ratings were assessed using a 5-point Likert scale. Exploratory efficacy parameters (freedom from pain and most bothersome symptom) were recorded in participants' electronic diaries.

resultsOverall, the majority of participants had favorable impressions of STS101, which were consistent across the assessments at 3-, 6-, and 12-month timepoints. STS101 was considered easy or very easy to use by 92.3%, 92.9%, and 91.2% of participants at months 3, 6, and 12, respectively. After 3, 6, and 12 months of use, 78.9%, 80.5%, and 73.7% of participants indicated they were likely or very likely to use STS101 if it was available. When asked at the 3-, 6-, and 12-month assessments to compare STS101 to their usual migraine medication, 63.9%, 74.1%, and 70.1% of participants agreed or strongly agreed that STS101 helped them return to normal faster than their usual medication. A total of 64.9%, 66.1%, and 69.3% of participants agreed or strongly agreed that STS101 worked faster and 67.0%, 73.7%, and 72.5% of participants agreed or strongly agreed that STS101 worked more consistently than their usual medication. Treatment with STS101 showed freedom from headache pain at 2, 4, 24, and 48 h postdose in 33.3%, 61.3%, 86.2%, and 91.1% of participants, respectively. Similar trends were seen in freedom from most bothersome symptom as reported by 53.3%, 78.0%, 91.9%, and 93.7% of participants at 2, 4, 24, and 48 h postdose, respectively.

conclusionParticipant impression data through 12 months suggest that STS101 was generally perceived as favorable by participants on multiple attributes. Most considered STS101 easy to use and indicated they would be likely to use the product if it were available. Exploratory efficacy evaluations indicated beneficial effects.