Phase 3
Completed N=834
Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention
Source: ClinicalTrials.gov NCT02848326 ↗Enrolled (actual)
834
Serious AEs
0.9%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period — -2.85; -4.00; -3.76; -3.55 migraine days per month — p=0.0039
◆ Published Evidence
Highly cited
230citations · ~38 / year
Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial.
Summary
This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.
Linked Publications (4)
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Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial.
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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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Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials.
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Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period |
-2.85; -4.00; -3.76; -3.55; -4.23; -4.14 | 0.0039 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period |
-2.93; -4.31; -4.17; -3.86; -4.23; -4.32 | 0.0014 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period |
40.4; 57.6; 53.3; 52.0; 58.2; 62.1 | 0.0617 |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period |
-2.42; -3.71; -3.86; -3.53; -3.77; -3.64 | 0.0002 sig |
Eligibility Criteria
Inclusion Criteria
- Has at least a 1-year history of migraine with or without aura
- Age of the patient at the time of migraine onset 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1
- Pregnant or nursing females
Data sourced from ClinicalTrials.gov (NCT02848326) 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.