ELEVATE
Trial question
What is the effect of atogepant in patients with episodic migraine who had previously failed conventional oral preventive treatments?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
89.0% female
11.0% male
N = 313
313 patients (280 female, 33 male).
Inclusion criteria: adult patients aged 18-80 years with episodic migraine who had previously failed 2-4 classes of conventional oral treatments for migraine prevention.
Key exclusion criteria: clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease; ≥ 15 headache days/month 3 months prior to the first visit; history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.
Interventions
N=156 atogepant (at an oral dose of 60 mg/day).
N=157 placebo (matching placebo).
Primary outcome
Least square mean reduction in monthly migraine days across 12 weeks
4.2 days
1.9 days
4.2 days
3.2 days
2.1 days
1.1 days
0.0 days
Atogepant
Placebo
Significant
increase ▲
Significant increase in least square mean reduction in monthly migraine days across 12 weeks (4.2 days vs. 1.9 days; MD 2.4, 95% CI 1.5 to 3.2).
Secondary outcomes
Significantly greater reduction of ≥ 50% in monthly migraine days across 12 weeks (51% vs. 18%; OR 4.8, 95% CI 2.9 to 8.1).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In adult patients aged 18-80 years with episodic migraine who had previously failed 2-4 classes of conventional oral treatments for migraine prevention, atogepant was superior to placebo with respect to least square mean reduction in monthly migraine days across 12 weeks.
Reference
Cristina Tassorelli, Krisztián Nagy, Patricia Pozo-Rosich et al. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392.
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