[M24-859]Atogepant for the Preventive Treatment of Menstrual Migraine

JRCT ID: jRCT2051240268

Registered date:13/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Menstrual Migraine
• Date of first enrollment: 13/02/2025
• Target sample size: 430
• Countries of recruitment: China,Japan,Czechia,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,South Korea,Japan,Taiwan,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

During the DB treatment period, subjects will take blinded atogepant 60 mg or placebo QD starting 3 days prior to start of menses and 1 day prior to the PMP and continue treatment for a total of 7 consecutive days per menstrual cycle for 3 cycles.
During the OL treatment period, subjects will take atogepant 60 mg QD for 7 consecutive days starting 3 days prior to the estimated start of menses for each cycle.

Outcome(s)

• Primary Outcome: Change in Number of Migraine Days Occurring During the Perimenstrual Period(PMP)

Secondary Outcome

-Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP
-Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs
-Change in Number of Acute Medication Use Days During PMP
-Change in Number of Moderate or Severe Headache Days During PMP
-Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs
-Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS)
-Change in Number of Headache Days During PMP

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

-History and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
-History of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
-Migraine onset before age 50 years.
-By history at Visit 1/Screening, subject meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinion of the investigator.
-Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day.

Exclude criteria

-History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by International Classification of Headache Disorders, 3rd Edition (ICHD-3).
-An average of 15 or more headache days per month recorded in the eDiary during the screening period.
-History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
-Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3.
-Required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
-Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
-Has a condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06806293