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Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
NCT06417775 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Ubrogepant
- DRUG Placebo for Ubrogepant
Study Locations (20)
California
- Hope Clinical Research /ID# 257867 — Canoga Park
- Axiom Research /ID# 257833 — Colton
- Neuro Pain Medical Center /ID# 257155 — Fresno
- Axiom Research, LLC-Los Angeles /ID# 264085 — Glendale
- Sun Valley Research Center /ID# 257152 — Imperial
- Axiom Research - Irvine /ID# 264083 — Irvine
- Collaborative Neuroscience Research CNS /ID# 257828 — Los Alamitos
- Los Angeles Headache Center /ID# 257237 — Los Angeles
- Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158 — Newport Beach
- Artemis Institute for Clinical Research - San Diego /ID# 257134 — San Diego
- M3 Wake Research - Convoy /ID# 257897 — San Diego
- Optimus Medical /ID# 257856 — San Francisco
Arizona
- MD First Research - Chandler /ID# 262564 — Chandler
- Gilbert Neurology /ID# 260179 — Gilbert
- Foothills Research Center/CCT Research /ID# 260180 — Phoenix
- Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309 — Tucson
Alabama
- Central Research Associates /ID# 260161 — Birmingham
- Rehabilitation & Neurological Services /ID# 275593 — Huntsville
Arkansas
- Preferred Research Partners /ID# 262786 — Little Rock
- Preferred Research Partners /ID# 273128 — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06417775
The ClinicalTrials.gov registry entry for NCT06417775 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 496 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions — of which Ubrogepant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06417775 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06417775 about?
NCT06417775 is a clinical study titled "Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine". 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 perim...
What is the current status of trial NCT06417775?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 496 participants. The study started on 2024-09-10. Estimated completion is 2027-09.
What conditions does trial NCT06417775 study?
This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06417775?
The interventions under investigation include: Ubrogepant (DRUG), Placebo for Ubrogepant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06417775?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06417775 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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