A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (ADVANCE)
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Episodic Migraine
- Sponsor
- Allergan
- Enrollment
- 910
- Locations
- 130
- Primary Endpoint
- Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
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 \<50 years.
Exclusion Criteria
- •Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine.
- •Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (e.g., 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.
- •Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Arms & Interventions
Placebo
Placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Placebo
Atogepant 10 mg
Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Atogepant
Atogepant 10 mg
Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Placebo
Atogepant 30 mg
Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Atogepant
Atogepant 30 mg
Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Placebo
Atogepant 60 mg
Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Atogepant
Atogepant 60 mg
Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period
Time Frame: Baseline (Day -28 to Day -1) to Week 12
Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration or acute symptomatic medication use. The monthly (4-week) migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of migraine days during the last 28 days of the Baseline phase, from Day -28 to -1. Negative change from Baseline indicates improvement. A Mixed-effects model for repeated measures (MMRM) was used for analysis.
Secondary Outcomes
- Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period(Baseline (Day-28 to Day -1) to Week 12)
- Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period(Baseline (Day-28 to Day -1) to Week 12)
- Percentage of Participants With at Least a 50% Reduction (Improvement) in 3-month Average of Monthly Migraine Days(Baseline (Day -28 to Day -1) to Week 12)
- Change From Baseline in Migraine-Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12(Baseline (Day 1) to Week 12)
- 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(Baseline (Day -28 to Day -1) to Week 12)
- 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(Baseline (Day -28 to Day -1) to Week 12)