Phase 3
N=315
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Episodic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04740827 ↗Enrolled (actual)
315
Serious AEs
1.3%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population — -1.86; -4.29 migraine days per month — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atogepant 60 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population |
-1.86; -4.29 | <0.0001 sig |
| PRIMARY Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population |
-1.85; -4.20 | <0.0001 sig |
| SECONDARY Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population |
27; 77 | <0.0001 sig |
| SECONDARY Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population |
28; 78 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population |
-1.93; -4.21 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population |
-1.91; -4.10 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population |
-1.11; -3.79 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population |
-1.10; -3.70 | <0.0001 sig |
| SECONDARY Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population |
15.41; 33.09 | <0.0001 sig |
| SECONDARY Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population |
15.38; 33.26 | <0.0001 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 in mITT Population |
-4.97; -9.68 | <0.0001 sig |
| SECONDARY Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population |
-3.03; -7.43 | <0.0001 sig |
| SECONDARY Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population |
-4.14; -10.56 | <0.0001 sig |
| SECONDARY Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
84; 81 | — |
Summary
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.
Eligibility Criteria
Inclusion Criteria
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
- Age of the participant at the time of migraine onset < 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
- 4 to 14 migraine days in the 28-day baseline period per eDiary
- Failed oral migraine prophylaxis medications from 2 to 4 medication classes
Exclusion Criteria
- Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
- Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
- In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
- Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
- Has ≥ 15 headache days in the 28-day baseline period per eDiary
- Clinically significant cardiovascular or cerebrovascular disease
- Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
- Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018
Data sourced from ClinicalTrials.gov (NCT04740827). 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.