Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Phase 3

Recruiting

• Conditions: Menstrual Migraine (MM)
• Interventions: Drug: Atogepant; Drug: Placebo for Atogepant

• Registration Number: NCT06806293
• Lead Sponsor: AbbVie

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, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM.

Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. Approximately 430 adult female participants with menstrual migraine will be enrolled in approximately 85 sites across the world.

Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Study Start: 2025-02-10
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-02
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 430

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atogepant	Atogepant	Participant will receive atogepant during Double-Blind period and Open-Label period.
Placebo for Atogepant	Atogepant	Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
Placebo for Atogepant	Placebo for Atogepant	Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.

Primary Outcome Measures

Name	Time	Method
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)	Up to approximately 120 days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

Secondary Outcome Measures

Name	Time	Method
Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP	Up to approximately 120 days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs	Up to approximately 120 days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Change in Number of Acute Medication Use Days During PMP	Up to approximately 120 days	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Change in Number of Moderate or Severe Headache Days During PMP	Up to approximately 120 days	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.
Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs	Up to approximately 120 days	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS)	Up to approximately 120 days	FDS is a single item used to measure the participant's level of functional disability.
Change in Number of Headache Days During PMP	Up to approximately 120 days	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

Trial Locations

Locations (86)

Chinese PLA General Hospital /ID# 267141; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital - Southern Medical University /ID# 268510; 🇨🇳 Guangzhou, Guangdong, China

Hebei General Hospital /ID# 267663; 🇨🇳 Shijiazhuang, Hebei, China

Renmin Hospital of Wuhan University /ID# 267671; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University /ID# 267885; 🇨🇳 Suzhou, Jiangsu, China

Shaanxi Provincial People'S Hospital /ID# 267827; 🇨🇳 XI An, Shaanxi, China

First Affiliated Hospital of Shanxi Medical University /ID# 267680; 🇨🇳 Taiyuan, Shanxi, China

Tianjin Medical University General Hospital /ID# 268846; 🇨🇳 Tianjin, Tianjin, China

Tianjin People's Hospital /ID# 268511; 🇨🇳 Tianjin, Tianjin, China

The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994; 🇨🇳 Hangzhou, Zhejiang, China

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