Treatment Consistency Across Multiple Migraine Attacks: Results From the Phase 3 Open-Label STOP 301 Study
posted in Presentations by Brooke Eger
Poster presented at the 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.
Authors: Richard B. Lipton, MD, Barbara L. Nye, MD, Joe Hirman, PhD, Sheena K. Aurora, MD, and Stephen B. Shrewsbury, MB ChB
Since people with migraine treat multiple attacks with acute medications, consistency of response is an important treatment attribute. Variability in gastrointestinal absorption and presence of gastroparesis, may contribute to inconsistent response. INP104, a novel drug-device product in development, targets delivery of dihydroergotamine mesylate to the upper nasal space using Precision Olfactory Delivery (POD®) technology. We hypothesized that INP104 could provide highly consistent headache response because delivery circumvents the gut.
To evaluate within-person consistency of response to INP104 by conducting a post hoc analysis of exploratory self-reported efficacy data from the Phase 3, open-label, STOP 301 safety study (NCT03557333).
A total of 188 patients self-administered INP104 (1.45 mg) and provided data on ≥4 migraine attacks in the first and second 12 weeks of the study. Daily eDiaries captured headache characteristics and treatment response. We defined 2-hour headache response (2hHR) by mild or no pain at 2 hours post-INP104. We evaluated consistency of response based on the proportion of patients who achieved 2hHR in these 3 consistency groups: 100%, 75% to < 100%, 67% to < 75%. Results from a patient acceptability and Migraine Disability Assessment (MIDAS) questionnaire are also reported.
Over 24 weeks, 17.6%, 59.6%, and 63.3% of patients achieved the 100%, 75% to <100% or better, and 67% to <75% or better consistency thresholds. Most 100% responders in the first 12 weeks were 100% responders in the second 12 weeks (65.2%), while the majority who were in the 75% < 100% responder range in the first 12 weeks achieved the same or better level of response over Weeks 13-24 (88.5%). As treatment consistency increased, reduction in MIDAS score declined and patient acceptability improved (Figure).
Patients who continued on INP104 treatment showed high levels of within-person consistency across multiple attacks over 24 weeks.
Lipton RB, Nye BL, Hirman J, Aurora SK, Shrewsbury SB, Treatment Consistency Across Multiple Migraine Attacks: Results From the Phase 3 Open-Label STOP 301 Study, 2021 American Headache Society (AHS) Virtual Annual Scientific Meeting.