Phase 3
N=778
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03855137 ↗Enrolled (actual)
778
Serious AEs
1.8%
Results posted
Feb 2023
Primary outcome: Primary: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population — -4.63; -7.13; -7.27 migraine days per month — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atogepant 30 mg (Drug); Atogepant 60 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population |
-4.63; -7.13; -7.27 | 0.0001 sig |
| PRIMARY Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population |
-4.65; -7.00; -7.19 | 0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population |
-4.26; -7.16; -6.71 | 0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population |
-4.33; -7.04; -6.59 | 0.0002 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population |
-3.57; -6.23; -6.33 | 0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population |
-3.56; -6.21; -6.00 | 0.0002 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population |
26.0; 42.7; 41.0 | 0.0003 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population |
26.5; 42.1; 40.1 | 0.0006 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 in Off-Treatment Hypothetical Estimand Population |
17.56; 25.73; 23.72 | 0.0006 sig |
| SECONDARY Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population |
-9.80; -14.56; -13.90 | 0.0003 sig |
| SECONDARY Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population |
-8.05; -12.34; -11.65 | 0.0003 sig |
| SECONDARY Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population |
-5.18; -8.97; -7.97 | 0.0006 sig |
Summary
This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
Eligibility Criteria
Inclusion Criteria
- At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
- Age of the participant at the time of migraine onset =15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
- >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
- Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
Exclusion Criteria
- Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
- History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
- Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.
Data sourced from ClinicalTrials.gov (NCT03855137). 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.