NCT06417775 · AbbVie
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
(UBRO MM)
What this study is about
A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles.
View original scientific description
A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after.
Interventions
DRUG
Ubrogepant
Oral Tablets
DRUG
Placebo for Ubrogepant
Oral Tablets
Primary outcome measures
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
Time frame: Up to approximately 16 Weeks
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 68 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At least a 1-year history of migraine with or without aura.
- Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
- Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
- Have regular menstrual cycles of between 21-35 days in length.
- Less than 15 headache days per month.
- At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.
Exclusion criteria
- History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
- Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
- Clinically significant abnormalities in the physical examination as determined by the investigator.
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecolo
Where
- Birmingham, Alabama
- Huntsville, Alabama
- Chandler, Arizona
- Gilbert, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Canoga Park, California
- Colton, California
- Fresno, California
- Glendale, California
- Imperial, California
And 83 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations