A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
524
Oral Tablet
Oral Tablet
Tokyo Dental College Ichikawa General Hospital /ID# 247436
Ichikawa-shi, Chiba, Japan
Takanoko Hospital /ID# 245658
Matsuyama, Ehime, Japan
Fukuiken Saiseikai Hospital /ID# 245662
Fukui-shi, Fukui, Japan
Jinnouchi Neurosurgical Clinic /ID# 245510
Kasuga-shi, Fukuoka, Japan
Ikeda Neurosurgical Clinic /ID# 245881
Kasuga-shi, Fukuoka, Japan
Change From Baseline in Mean Monthly Migraine Days
Participants recorded daily duration of migraine in an eDiary. 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 eDiary divided by total number of days with eDiary 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 Measure (MMRM) was used for analysis.
Time frame: Up to Week 12
Number of Participants Experiencing With Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Week 12
Change From Baseline in Mean Monthly Headache Days
Participants recorded daily total duration of a headache in an eDiary. A headache day is any calendar day on which the participant experienced a headache qualified by duration or acute symptomatic medication use. The monthly (4-week) headache days were defined as the total number of reported headache days in the eDiary divided by the total number of days with eDiary 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. MMRM was used for analysis.
Time frame: Up to Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days
Participants recorded allowed medication(s) to treat an acute migraine in the daily eDiary. The monthly (4-week) acute medication use days was defined as the total number of reported acute medication use days in the eDiary divided by the total number of days with eDiary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Baseline was defined as the number of acute medication use days during the last 28 days of the Baseline phase, from Day -28 to -1. A negative change from Baseline indicates improvement. MMRM was used for the analysis.
Time frame: Up to Week 12
Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days
Participants recorded daily duration of migraine in an eDiary. 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 is equal to total number of reported migraine days in eDiary divided by total number of days with eDiary records in each 4-week period multiplied by 28. Each 4-week period was averaged.
Time frame: Up to Week 12
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score
MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality-of-life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: role function-restrictive (questions 1-7, score range 7 to 42) assesses how migraines limit one's daily social and work-related activities; role function-preventive (questions 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the emotional function (questions 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale where 1=none of the time and 6=all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores from Baseline indicate better quality of life. MMRM was used for the analysis.
Time frame: Up to Week 12
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.
Time frame: Up to Week 12
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D
The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.
Time frame: Up to Week 12
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SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948
Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital /ID# 246683
Hiroshima, Hiroshima, Japan
Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667
Sapporo, Hokkaido, Japan
Nakamura Memorial Hospital /ID# 247379
Sapporo, Hokkaido, Japan
Konan Medical Center /ID# 245557
Kobe, Hyōgo, Japan
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