Clinical Trials List
Protocol NumberM24-859
NCT Number(ClinicalTrials.gov Identfier)NCT06806293
Active
2024-12-01 - 2028-01-31
Phase III
Recruiting5
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine
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Trial Applicant
AbbVie
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Sponsor
ABBVIE BIOPHARMACEUTICALS GMBH TAIWAN BRANCH (SWITZERLAND)
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/14
Investigators and Locations
Co-Principal Investigator
- Yuan-Ting Sun Division of Neurology
- 王淳民 Division of Neurology
- 吳牧韓 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-FENG WANG 無
- 陳世彬 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Ting Hsu 無
- Kuan-Fei Chen 無
- Fu-Yu Lin 無
- Ching-Hua Lu Lu 無
- Yu Ao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Long-Sun Ro
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Menstrual Migraine (MM)
Objectives
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.
Test Drug
Atogepant
Active Ingredient
N02CD07000
Dosage Form
N/A
Dosage
N/A
Endpoints
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. Up to approximately 120 days
Inclution 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.
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.
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.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
430 participants
