Phase 3
Completed N=910
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
Source: ClinicalTrials.gov NCT03777059 ↗Enrolled (actual)
910
Serious AEs
0.4%
Results posted
Jul 2021
Primary outcomePrimary: Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period — -2.48; -3.69; -3.86; -4.20 migraine days per month — p=<.0001
◆ Published Evidence
Emerging
10citations · ~10 / year
Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
Summary
To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.
Linked Publications (5)
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Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials.
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Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials.
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Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
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Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial.
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Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period |
-2.48; -3.69; -3.86; -4.20 | <.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period |
-2.52; -3.94; -4.04; -4.23 | <.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period |
-2.35; -3.66; -3.68; -3.85 | <.0001 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days |
29.0; 55.6; 58.7; 60.8 | <.0001 sig |
| SECONDARY Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 |
20.45; 30.35; 30.53; 31.25 | <.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine-Diary (AIM-D) Across the 12-Week Treatment Period |
-6.09; -7.28; -8.63; -9.41 | 0.0856 |
| SECONDARY Change From Baseline in Mean Monthly Physical Impairment Domain Score of the Activity Impairment in Migraine- Diary (AIM-D) Across the 12-Week Treatment Period |
-4.03; -5.11; -6.02; -6.49 | 0.0743 |
Eligibility Criteria
Inclusion Criteria
- At least a 1-year history of migraine with or without aura consistent with a diagnosis.
- Age of the participant at the time of migraine onset 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Data sourced from ClinicalTrials.gov (NCT03777059) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.