A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ATOGEPANT FOR THE PREVENTION OF CHRONIC MIGRAINE (PROGRESS)

INTERVENTION: Product Name: Atogepant Pharmaceutical Form: Tablet INN or Proposed INN: Atogepant CAS Number: 1374248‐81‐3 Current Sponsor code: AGN‐241689 Other descriptive name: MK‐8031; L‐004880174‐008A; L‐004880174; C11051808‐H Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Atogepant Pharmaceutical Form: Tablet INN or Proposed INN: Atogepant CAS Number: 1374248‐81‐3 Current Sponsor code: AGN‐241689 Other descriptive name: MK‐8031; L‐004880174‐008A; L‐004880174; C11051808‐H Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Chronic migraine ; MedDRA version: 21.1 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and atogepant 60 mg once daily for the prevention of chronic migraine (CM).; To prospectively test for superiority of atogepant 30 mg twice per day (BID) and atogepant 60 mg once daily versus placebo for the prevention of CM. Primary end point(s): The primary efficacy endpoint is the change from baseline in mean monthly migraine days across the 12‐week treatment period. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: From baseline to Week 12. Baseline is defined as the number of migraine days during the last 28 days of the baseline phase (ie, Day ‐28 to ‐1). SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy endpoints for the European Union and Canada:; ‐ Change from baseline in mean monthly headache days across the 12‐week treatment period; ‐ Change from baseline in mean monthly acute medication use days across the 12‐week treatment period; ‐ Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12‐week treatment period; ‐ Change from baseline in the HIT‐6 total score at Week 12; ‐ Change from baseline in MSQ v2.1 Role Function‐Restrictive domain score at Week 12 Timepoint(s) of evaluation of this end point: From baseline to Week 12. Baseline is defined as the number of migraine days during the last 28 days of the baseline phase (ie, Day ‐28 to ‐1). INCLUSION CRITERIA: 1. Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study‐specific procedures 2. Male or female participants ages 18 to 80 years, inclusive, at Visit 1 3. At least a 1‐year history of CM consistent with a diagnosis according to the ICHD 3, 2018 4. Age of the participant at the time of migraine onset < 50 years 5. Confirmation of headache/migraine headache day frequency as follows: a. History of, on average, = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND b. = 15 headache days during the 4‐week screening/baseline period per the electronic diary (eDiary) AND c. = 8 days during the 4‐week screening/baseline period that qualify as being a migraine day per the eDiary 6. Completed at least 20 out of 28 days in the eDiary during baseline