Status:
RECRUITING
Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Lead Sponsor:
AbbVie
Conditions:
Menstrual Migraine (MM)
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivi...
Eligibility Criteria
Inclusion 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, participant 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 participant experiences and records a migraine attack in the eDiary with at least 1 migraine day.
Exclusion 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 participant or the quality of the data and renders the subject an unsuitable candidate for the study.
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06806293
Start Date
February 10 2025
End Date
July 1 2027
Last Update
March 6 2026
Active Locations (95)
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1
Chinese PLA General Hospital /ID# 267141
Beijing, Beijing Municipality, China, 100039
2
Nanfang Hospital - Southern Medical University /ID# 268510
Guangzhou, Guangdong, China, 510000
3
Hebei General Hospital /ID# 267663
Shijiazhuang, Hebei, China, 500051
4
Renmin Hospital of Wuhan University /ID# 267671
Wuhan, Hubei, China, 430060