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A Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine
EU CTIS ID: 2024-512946-41-00
What this study is testing
The primary objective is to evaluate the efficacy of atogepant taken consecutively for 7 days compared to placebo for the preventive treatment of MM.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult individuals, at least 18 years old, who by 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 ICHD-3 for ≥ 12 months prior to Visit 1/Screening.
- Migraine onset before age 50 years.
- By history at Visit 1/Screening, subject 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.
- Subject records 3 PMPs in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day.
You likely can't join if
- 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 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.
- Subject 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.
See the full eligibility criteria
- Adult individuals, at least 18 years old, who by 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 ICHD-3 for ≥ 12 months prior to Visit 1/Screening.
- Migraine onset before age 50 years.
- By history at Visit 1/Screening, subject 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.
- Subject records 3 PMPs in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day.
- 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 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.
- Subject 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.
- Subject has a condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- China
- Korea, Republic of
- Taiwan
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; China; Korea, Republic of; Taiwan; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.