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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
430
Oral Tablet
Oral Tablet
Chinese PLA General Hospital /ID# 267141
Beijing, Beijing Municipality, China
RECRUITINGNanfang Hospital - Southern Medical University /ID# 268510
Guangzhou, Guangdong, China
RECRUITINGHebei General Hospital /ID# 267663
Shijiazhuang, Hebei, China
RECRUITINGRenmin Hospital of Wuhan University /ID# 267671
Wuhan, Hubei, China
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)
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
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 Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs
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
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
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
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)
FDS is a single item used to measure the participant's level of functional disability.
Time frame: Up to approximately 120 days
Change in Number of Headache Days During PMP
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The First Affiliated Hospital of Soochow University /ID# 267885
Suzhou, Jiangsu, China
RECRUITINGShaanxi Provincial PeopleS Hospital /ID# 267827
Xi'an, Shaanxi, China
RECRUITINGFirst Affiliated Hospital of Shanxi Medical University /ID# 267680
Taiyuan, Shanxi, China
RECRUITINGTianjin Medical University General Hospital /ID# 268846
Tianjin, Tianjin Municipality, China
RECRUITINGTianjin People's Hospital /ID# 268511
Tianjin, Tianjin Municipality, China
RECRUITINGThe Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
Hangzhou, Zhejiang, China
RECRUITING...and 85 more locations