Clinical Trials List
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
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳世彬 無
- YEN-FENG WANG 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yi-Ting Hsu 無
- Yu Ao 無
- Kuan-Fei Chen 無
- Fu-Yu Lin 無
- Ching-Hua Lu Lu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王淳民 無
- 吳牧韓 無
- Yuan-Ting Sun 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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.
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.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
430 participants
