PROGRESS (atogepant 60 mg OD)
Trial question
What is the role of atogepant in patients with chronic migraine?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
87.0% female
13.0% male
N = 516
516 patients (450 female, 66 male).
Inclusion criteria: adult patients aged 18-80 years with ≥ 1 year history of chronic migraine.
Key exclusion criteria: cluster headache; painful cranial neuropathy; history of inadequate response to > 4 preventive migraine treatments; use of opioids or barbiturates for at least 4 days per month in the previous 3 months.
Interventions
N=261 atogepant (at an oral dose of 60 mg once daily).
N=255 placebo (matching placebo).
Primary outcome
Least-square mean reduction in monthly migraine days across 12 weeks
6.9 days
5.1 days
6.9 days
5.2 days
3.5 days
1.7 days
0.0 days
Atogepant
Placebo
Significant
increase ▲
Significantly greater reduction in least-square mean monthly migraine days across 12 weeks (6.9 days vs. 5.1 days; MD 1.8, 95% CI 0.8 to 2.9).
Secondary outcomes
Significantly greater reduction in least-square mean monthly headache days (7 days vs. 5.1 days; MD 1.9, 95% CI 0.8 to 2.9).
Significantly greater reduction in mean monthly acute medication use days (6.2 days vs. 4.1 days; MD 2.1, 95% CI 1.1 to 3.1).
Significant increase in ≥ 50% reduction in 3 month average of monthly migraine days (41% vs. 26%; OR 2, 95% CI 1.4 to 3).
Safety outcomes
No significant difference in treatment-emergent serious adverse events.
Conclusion
In adult patients aged 18-80 years with ≥ 1 year history of chronic migraine, atogepant was superior to placebo with respect to a least-square mean reduction in monthly migraine days across 12 weeks.
Reference
Patricia Pozo-Rosich, Jessica Ailani, Messoud Ashina et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785.
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