Poster Number-4 - Improvements in Productivity and Disability With INP104 as Assessed by the Migraine Disability Assessment Scale (MIDAS): Results From the Phase 3 STOP 301 Study

Migraine is a highly prevalent, disabling disorder with significant patient burden. New and effective acute therapies that improve the migraine symptoms responsible for patient burden remains an unmet need. INP104 is a drug-device combination product of dihydroergotamine mesylate and Precision Olfactory Delivery (POD®) approved for the acute treatment of migraine. The safety, tolerability, and exploratory efficacy of long-term INP104 use was assessed in the phase 3 STOP 301 trial in migraine patients. As part of this study, migraine-associated disability was evaluated using the Migraine Disability Assessment Scale (MIDAS) questionnaire. Here, the scores are reported for each item of the MIDAS questionnaire following long-term treatment with INP104.

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. Inclusion criteria included adult migraine patients with or without aura not qualifying as chronic migraine; having ≥2 migraine attacks per month for the previous 6 months and during the 28-day screening period; and being in general good health with no history of cardiovascular risk factors or diseases. Following a 28-day screening period, during which patients treated migraine attacks with their best usual care, eligible patients received INP104 (1.45 mg) to self-administer nasally with self-recognized migraine attacks. The MIDAS questionnaire is a validated instrument measuring the headache-related disability affecting patients, with a grading system to categorize the degree of disability. 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, at baseline, at Weeks 12 and 24, and if applicable, at Weeks 36 and 52. MIDAS total scores were determined based on the sum of questions 1-5 for all nonmissing data.

Results:

Overall, 360 patients were screened and enrolled in the STOP 301 study, with 354 patients having self-administered ≥1 INP104 dose over 24 weeks. A total of 73 patients continued into the 52-week extension period. The MIDAS 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 scores were 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 with productivity in household work 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. On a scale of 1 to 10, mean headache pain intensity was 7.3, 7.0, 7.0, and 7.1 at Weeks 12, 24, 36, and 52, respectively, compared with 7.0 at baseline.

 

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.

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