PROGRESS study

A 12-week, multicentre, double-blind, parallel-group, randomised, placebo-controlled Phase 3 trial to examine the efficacy and safety of AQUIPTA™ for the prevention of chronic migraine.^1,2 Participants were randomly assigned to AQUIPTA™ 60 mg once a day (n=262) or placebo (n=259).*¹

The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period.^†1,2 Secondary endpoints included change from baseline in the mean monthly headache days across the 12-week treatment period; change from baseline in mean monthly acute medication use days across the 12-week treatment period; reduction from baseline of at least 50% in the 3-month average of mean monthly migraine days; change from baseline in mean monthly AIM-D PDA and PI domain across 12 weeks;^‡ change from baseline in HIT-6 score at Week 12^§ and change from baseline in MSQ v2.1 RFR score at Week 12.¹

Patients were included if they were 18–80 years of age, had a headache/migraine day frequency of ≥15 days per month in the 3 months before the baseline screening visit and during the 4-week baseline period (of which ≥8 were migraine days), had at least a 1-year history of migraine diagnosed as specified in the ICHD, with migraine onset before 50 years of age, who were using medically acceptable and effective birth control, and completed the headache electronic diary (eDiary) on at least 20 days of the 28-day baseline period.¹

Patients were excluded if they had new daily persistent headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by the ICHD-3; had an inadequate response to >4 oral medications prescribed for the preventive treatment of migraine (≥2 having different mechanisms of action); used opioids or barbiturates for ≤4 days per month in the 3 months before Visit 1 or during the baseline period and any use of barbituates in the 30 days before screening or during the trial; were pregnant, planning to become pregnant during the trial or currently lactating; had any clinically significant diseases (e.g. endocrine, cardiovascular, cerebrovascular or neurological).¹ Participants with myocardial infarction, stroke or transient ischaemic attacks within 6 months prior to screening were also excluded.²

AIM-D, Activity Impairment in Migraine-Diary; HIT-6, 6-item Headache Impact Test; ICHD, International Classification of Headache Disorders; IE, Ireland; MSQ, Migraine-Specific Quality of Life Questionnaire; PDA, Performance of Daily Activities; PI, Physical Impairment; RFR, Role Function-Restrictive.

*Eligible participants were randomised 1:1:1 to AQUIPTA™ or placebo arms with interactive response technology and stratified by baseline acute headache medication overuse, previous exposure to effective migraine-prevention medication and number of preventive medications failed with unique mechanisms (“0 or ≥1 medication(s) with the same mechanism” or “failed 2–4 medications with different mechanisms”), and region.¹ †The mean number of migraine days per month were calculated using the average number of migraine days during Weeks 1–4, 5–8 and 9–12. Baseline was defined as the number of migraine days during the 28 days before randomisation. Efficacy assessments, including baseline values, were recorded by the participant at home using an electronic diary at home or through an electronic tablet.¹ ‡Change from baseline in mean monthly AIM−D PDA and PI scores across the 12-week treatment period was an additional secondary efficacy endpoint in all regions other than Canada and Europe.¹ §Change from baseline in HIT-6 score at Week 12 was an additional secondary efficacy endpoint in Europe and Canada only.¹

References:

1. Pozo-Rosich P, et al. Lancet. 2023;402(10404):775–785 (Supplementary Appendix).
2. AQUIPTA™ (atogepant) IE Summary of Product Characteristics. August 2023.