Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine (NCT06417775)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Central Research Associates /ID# 260161 — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (106 Sites)
Showing the first 25 of 106 sites.
- Central Research Associates /ID# 260161 — Birmingham, Alabama
- Rehabilitation and Neurological Services /ID# 275593 — Huntsville, Alabama
- MD First Research - Chandler /ID# 262564 — Chandler, Arizona
- Gilbert Neurology /ID# 260179 — Gilbert, Arizona
- Foothills Research Center/CCT Research /ID# 260180 — Phoenix, Arizona
- Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309 — Tucson, Arizona
- Preferred Research Partners /ID# 262786 — Little Rock, Arkansas
- Preferred Research Partners /ID# 273128 — Little Rock, Arkansas
- Hope Clinical Research /ID# 257867 — Canoga Park, California
- Axiom Research /ID# 257833 — Colton, California
- Neuro Pain Research Center /ID# 257155 — Fresno, California
- Axiom Research, LLC-Los Angeles /ID# 264085 — Glendale, California
- Sun Valley Research Center /ID# 257152 — Imperial, California
- Axiom Research - Irvine /ID# 264083 — Irvine, California
- CenExel Collaborative Neuroscience Research /ID# 257828 — Los Alamitos, California
- BNL Health - Los Angeles Headache Center /ID# 257237 — Los Angeles, California
- M3 Wake Research - Newport Beach /ID# 257158 — Newport Beach, California
- Artemis Institute for Clinical Research - San Diego /ID# 257134 — San Diego, California
- M3 Wake Research - Convoy /ID# 257897 — San Diego, California
- Optimus Medical /ID# 257856 — San Francisco, California
- New England Institute for Clinical Research /ID# 264019 — Stamford, Connecticut
- Neurology Offices of South Florida, PLLC /ID# 257161 — Boca Raton, Florida
- Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403 — DeLand, Florida
- Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874 — Lakeland, Florida
- Well Pharma Medical Research /ID# 257199 — Miami, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Migraine
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- A Study to Evaluate White Matter Hyperintensities in Migraine — Phoenix, Arizona
- Migraine Manager (R01) — Cincinnati, Ohio
- Nerivio Efficacy Under High-Frequency Use — Bridgewater, New Jersey
Explore by condition: All Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.