NCT06417775 Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
| NCT ID | NCT06417775 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AbbVie |
| Condition | Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 496 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 496 participants in total. It began in 2024-09-10 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed. Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico. Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility Criteria
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, gynecological, or neurologic disease per the investigator's opinion. * Acute headache medication overuse.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT06417775 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06417775 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 496 participants.
Is NCT06417775 currently recruiting?
Yes, NCT06417775 is actively recruiting participants. Contact the research team at abbvieclinicaltrials@abbvie.com for enrollment information.
Where is the NCT06417775 trial being conducted?
This trial is being conducted at Birmingham, United States, Huntsville, United States, Chandler, United States, Gilbert, United States and 11 additional locations.
Who is sponsoring the NCT06417775 clinical trial?
NCT06417775 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 496 participants.
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