Abstract Details

A better understanding of the key areas of unmet need regarding acute migraine therapy may help inform drug development and treatment selection.

The objective of this study was to characterize the areas of greatest unmet needs regarding acute migraine therapy, as determined by the 4-item Migraine Treatment Optimization Questionnaire (mTOQ-4).

The Phase 3 MOMENTUM trial (N=1594) assessed the efficacy and safety of AXS-07 (MoSEIC™ meloxicam and rizatriptan), meloxicam alone, rizatriptan alone, and placebo in a 4-arm acute migraine treatment trial.  Eligible patients had to have a history of inadequate response to prior acute treatments, assessed using the mTOQ-4, prior to enrollment. 

The mTOQ-4 assesses the frequency of efficacy response to acute treatment in four domains: Q1: two-hour pain freedom (2hPF), Q2: sustained pain freedom (SPF), Q3: ability to plan daily activities, and Q4: disruption of daily activities.  Response options included: never (0), rarely (0), less than half the time (1), or half the time or more (2).

For this analysis, we examined the proportion of subjects responding "Never" or "Rarely" to each of the mTOQ items to characterize the relative frequency of unmet need in each mTOQ domain.

At baseline, the mean total mTOQ score was 3.6, indicating poor response to prior acute therapies.  The proportions of participants answering "Never" or "Rarely" to the individual mTOQ items were: 33.4% for 2hPF, 43.2% for SPF, 40.5% for ability to plan, and 29.3% for disruption of daily activity.

Between 29-43% of people with migraine rarely or never experience a positive efficacy response to each of the four mTOQ domains.  Novel therapies that provide sustained pain freedom and improve the perceived ability to plan daily activities are particularly needed.