A Phase 3 interventional study of Atogepant and Placebo for Atogepant in Menstrual Migraine (MM), sponsored by AbbVie. Active, not recruiting at 95 sites in 12 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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. 468 adult female participants with menstrual migraine are enrolled in approximately 92 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.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant will receive atogepant during Double-Blind period and Open-Label period.
Drug: Atogepant
Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
Drug: Atogepant · Drug: Placebo for Atogepant
Oral Tablet
Also known as: Qulipta, Aquipta
Oral Tablet
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time frame: Up to approximately 120 days
Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time frame: Up to approximately 120 days
Change in Number of Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period
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.
Time frame: Up to approximately 120 days
Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time frame: Up to approximately 120 days
Change in Number of Acute Medication Use Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period
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.
Time frame: Up to approximately 120 days
Change in Number of Moderate or Severe Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period
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.
Time frame: Up to approximately 120 days
Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Time frame: Up to approximately 120 days
Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS) Across 3 Menstrual Cycles During the Double-Blind Period
FDS is a single item used to measure the participant's level of functional disability.
Time frame: Up to approximately 120 days
Percentage of Participants With No Difficult At All/Little Difficult in Thinking Clearly for 100% of PMP Days As Assessed by Cognitive Function Scale (CFS) Across 3 Menstrual Cycles During the Double-Blind Period
Cognitive Function Scale is a single item used to measure the subject's difficulty in thinking clearly.
Time frame: Up to approximately 120 days
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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