Improvements in Productivity and Disability With INP104 as Assessed by the Migraine Disability Assessment Scale (MIDAS): Results From the Phase 3 STOP 301 Study

Presented at the Diamond Headache Update Meeting, July 14-17, 2022

Authors: Christina Treppendahl, FNP-BC, AQH, MHD; Dawn C. Buse, PhD; Robert Vann, PhD; Christopher Fitzpatrick, PhD; Michelle Murphy, PhD; Stephen B. Shrewsbury, MBChB; Sheena K. Aurora, MD

Introduction: As part of the STOP 301 study, migraine-associated disability was assessed using the MIDAS questionnaire.

Objective: To report scores for each item of the Migraine Disability Assessment Scale (MIDAS) questionnaire following long-term treatment with INP104, a drug-device combination product of dihydroergotamine mesylate (DHE) and Precision Olfactory Delivery (POD®) technology for the acute treatment of migraine.

Methods: STOP 301 was a Phase 3, open-label, 24-week safety and exploratory efficacy study with a 28-week extension period for a subset of patients. After a 28-day screening period in which patients treated migraine attacks with their “best usual care,” INP104 (1.45 mg) was self-administered nasally with self recognized attacks. Patients were instructed to treat their migraine attacks with ≤2 doses within 24 hours and ≤3 doses per 7 days. The MIDAS questionnaire included 5 scored questions that measured the number of days in the past 3 months of limitations in daily activities at work, school, social, and leisure resulting from migraine. It was completed by patients during screening, baseline, at Weeks 12 and 24, and if applicable, at Weeks 36 and 52.

Results: The study population included 354, 283, 209, 69, and 65 patients for baseline, Week 12, Week 24, Week 36, and Week 52, respectively. The mean MIDAS total score was 18.4, 17.4, 15.3, and 14.9 at Weeks 12, 24, 36, and 52, respectively, compared with 25.1 at baseline. The mean number of headache days in the past 3 months was 11.3, 10.1, 9.1, and 10.5 at Weeks 12, 24, 36, and 52, respectively, compared with 15.9 at baseline. The mean number of school or work days missed because of headache in the past 3 months was 1.7, 1.8, 1.5, and 1.7 at Weeks 12, 24, 36, and 52, respectively, compared with 2.4 at baseline. The mean number of school or workdays with productivity reduced by half because of headache in the past 3 months was 4.6, 3.9, 3.4, and 3.3 at Weeks 12, 24, 36, and 52, respectively, compared with 5.6 at baseline. The mean number of days of missed household work because of headache in the past 3 months was 5.2, 5.3, 4.2, and 4.4 at Weeks 12, 24, 36, and 52, respectively, compared with 7.2 at baseline. The mean number of days where productivity in household work was reduced by half because of headache in the past 3 months was 4.5, 3.9, 3.5, and 3.1 at Weeks 12, 24, 36, and 52, respectively, compared with 6.5 at baseline. The mean number of days of missed family, social, or leisure activities because of headache in the past 3 months was 2.5, 2.6, 2.7, and 2.4 at Weeks 12, 24, 36, and 52, respectively, compared with 3.4 at baseline. The average headache pain intensity on a scale of 1 to 10 was 7.3, 7.0, 7.0, and 7.1 at Weeks 12, 24, 36, and 52, respectively, compared with 7.0 at baseline (Table 1).

Conclusion: Long-term INP104 use was associated with improvements in scores of several individual MIDAS items of productivity and disability as well as a decrease in the number of headache days over 24 and 52 weeks, leading to a reduction in overall patient burden.