Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Public ClinicalTrials.gov record NCT06417775. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06417775
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 496 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 10, 2024 (Actual)
- Primary completion
- Nov 2027 (Estimated)
- Completion
- Nov 2027 (Estimated)
- Last update posted
- Aug 14, 2026
2024 – 2027
United States locations
- U.S. sites
- 103
- U.S. states
- 39
- U.S. cities
- 95
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Research Associates /ID# 260161 | Birmingham | Alabama | 35205 | — |
| Rehabilitation and Neurological Services /ID# 275593 | Huntsville | Alabama | 35805 | — |
| MD First Research - Chandler /ID# 262564 | Chandler | Arizona | 85286 | — |
| Gilbert Neurology /ID# 260179 | Gilbert | Arizona | 85297 | — |
| Foothills Research Center/CCT Research /ID# 260180 | Phoenix | Arizona | 85044 | — |
| Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309 | Tucson | Arizona | 85741 | — |
| Preferred Research Partners /ID# 262786 | Little Rock | Arkansas | 72211 | — |
| Preferred Research Partners /ID# 273128 | Little Rock | Arkansas | 72211 | — |
| Hope Clinical Research /ID# 257867 | Canoga Park | California | 91303 | — |
| Axiom Research /ID# 257833 | Colton | California | 92324 | — |
| Neuro Pain Research Center /ID# 257155 | Fresno | California | 93710 | — |
| Axiom Research, LLC-Los Angeles /ID# 264085 | Glendale | California | 91206 | — |
| Sun Valley Research Center /ID# 257152 | Imperial | California | 92251-9401 | — |
| Axiom Research - Irvine /ID# 264083 | Irvine | California | 92604 | — |
| CenExel Collaborative Neuroscience Research /ID# 257828 | Los Alamitos | California | 90720 | — |
| BNL Health - Los Angeles Headache Center /ID# 257237 | Los Angeles | California | 90067-2001 | — |
| M3 Wake Research - Newport Beach /ID# 257158 | Newport Beach | California | 92660 | — |
| Artemis Institute for Clinical Research - San Diego /ID# 257134 | San Diego | California | 92103-2204 | — |
| M3 Wake Research - Convoy /ID# 257897 | San Diego | California | 92111 | — |
| Optimus Medical /ID# 257856 | San Francisco | California | 94102 | — |
| New England Institute for Clinical Research /ID# 264019 | Stamford | Connecticut | 06905 | — |
| Neurology Offices of South Florida, PLLC /ID# 257161 | Boca Raton | Florida | 33428-2231 | — |
| Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403 | DeLand | Florida | 32720 | — |
| Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874 | Lakeland | Florida | 33803 | — |
| Well Pharma Medical Research /ID# 257199 | Miami | Florida | 33143 | — |
| Indago Research and Health Center /ID# 277943 | Miami Lakes | Florida | 33016 | — |
| Sensible Healthcare /ID# 257198 | Ocoee | Florida | 34761 | — |
| Clinical Neuroscience Solutions, Inc /ID# 257190 | Orlando | Florida | 32801-2986 | — |
| Conquest Research /ID# 258314 | Winter Park | Florida | 32789 | — |
| NeuroTrials Research /ID# 274507 | Atlanta | Georgia | 30328 | — |
| Clinical Research Atlanta - Headlands LLC /ID# 260181 | Stockbridge | Georgia | 30281-9054 | — |
| Hawaii Pacific Neuroscience /ID# 274469 | Honolulu | Hawaii | 96817 | — |
| Velocity Clinical Research - Boise /ID# 257135 | Meridian | Idaho | 83642 | — |
| Healthcare Research Network /ID# 257868 | Tinley Park | Illinois | 60477 | — |
| Deaconess Midtown Hospital /ID# 257400 | Evansville | Indiana | 47710 | — |
| Accellacare - McFarland Clinic /ID# 257834 | Ames | Iowa | 50010 | — |
| Alliance for Multispecialty Research LLC /ID# 257839 | Newton | Kansas | 67114 | — |
| Collective Medical Research /ID# 257131 | Overland Park | Kansas | 66210 | — |
| Alliance For Multispeciality Research - Wichita East /ID# 257148 | Wichita | Kansas | 67207 | — |
| Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146 | Marrero | Louisiana | 70072 | — |
| IMA Clinical Research Monroe - Wood /ID# 259362 | Monroe | Louisiana | 71201 | — |
| Headlands PharmaSite /ID# 257208 | Baltimore | Maryland | 21208 | — |
| Boston Clinical Trials /ID# 257132 | Boston | Massachusetts | 02131-2515 | — |
| BTC of New Bedford /ID# 257128 | New Bedford | Massachusetts | 02740 | — |
| MedVadis Research /ID# 257156 | Waltham | Massachusetts | 02451 | — |
| Michigan Headache & Neurological Institute (MHNI) /ID# 257179 | Ann Arbor | Michigan | 48104-5131 | — |
| Memorial Healthcare Institute For Neuroscience /ID# 274663 | Owosso | Michigan | 48867 | — |
| Proven Endpoints LLC /ID# 273796 | Ridgeland | Mississippi | 39157 | — |
| HealthCare Research Network - Hazelwood /ID# 257402 | Hazelwood | Missouri | 63042 | — |
| Clinvest Research LLC /ID# 257215 | Springfield | Missouri | 65807 | — |
| Methodist Physicians Clinic/CCT Research /ID# 260167 | Fremont | Nebraska | 68025 | — |
| Cognitive Clinical Trials (CCT) - Papillion /ID# 260174 | Papillion | Nebraska | 68046-4131 | — |
| IMA Clinical Research Las Vegas /ID# 258679 | Las Vegas | Nevada | 89102-1955 | — |
| M3 Wake Research-Las Vegas Rainbow /ID# 257895 | Las Vegas | Nevada | 89118-2557 | — |
| Bio Behavioral Health, Inc /ID# 257140 | Toms River | New Jersey | 08755-6434 | — |
| IMA Clinical Research Warren /ID# 263641 | Warren Township | New Jersey | 07059 | — |
| Albuquerque Clinical Trials, Inc. /ID# 257212 | Albuquerque | New Mexico | 87102 | — |
| Dent Neurologic Institute - Amherst /ID# 257219 | Amherst | New York | 14226 | — |
| IMA Clinical Research Westchester /ID# 259157 | Hartsdale | New York | 10530 | — |
| Fieve Clinical Research, Inc. /ID# 257177 | New York | New York | 10017-1921 | — |
| Rochester Clinical Research /ID# 257193 | New York | New York | 14609 | — |
| True North Neurology /ID# 274672 | Port Jefferson Station | New York | 11776 | — |
| Upstate Clinical Research Associates /ID# 257163 | Williamsville | New York | 14221-6046 | — |
| Headache Wellness Center /ID# 257136 | Greensboro | North Carolina | 27405 | — |
| Accellacare - South Hawthorne Road - Winston-Salem /ID# 257731 | Winston-Salem | North Carolina | 27103 | — |
| Accellacare - South Hawthorne Road - Winston-Salem /ID# 257850 | Winston-Salem | North Carolina | 27103 | — |
| Lillestol Research, LLC /ID# 257896 | Fargo | North Dakota | 58104 | — |
| CTI Clinical Research Center /ID# 257162 | Cincinnati | Ohio | 45212-3784 | — |
| C7 Research /ID# 272815 | Cleveland | Ohio | 44109 | — |
| Centricity Research Columbus /ID# 257221 | Columbus | Ohio | 43213 | — |
| Wright State Physicians Health Center /ID# 274708 | Fairborn | Ohio | 45324 | — |
| Lynn Institute of Oklahoma City /ID# 257857 | Oklahoma City | Oklahoma | 73112 | — |
| Central States Research /ID# 277867 | Tulsa | Oklahoma | 74136 | — |
| Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139 | Portland | Oregon | 97210 | — |
| Abington Neurological Associates - Abington /ID# 257164 | Abington | Pennsylvania | 19001 | — |
| Clinical Research of Philadelphia, LLC /ID# 257197 | Philadelphia | Pennsylvania | 19114 | — |
| Partners In Clinical Research /ID# 257855 | Cumberland | Rhode Island | 02864 | — |
| Premier Neurology /ID# 260359 | Greenville | South Carolina | 29605 | — |
| Coastal Carolina Research Center - North Charleston /ID# 257227 | North Charleston | South Carolina | 29405 | — |
| WR-ClinSearch /ID# 257160 | Chattanooga | Tennessee | 37421-1605 | — |
| KCA Neurology /ID# 274495 | Franklin | Tennessee | 37067 | — |
| Alliance for Multispecialty Research - Knoxville /ID# 257846 | Knoxville | Tennessee | 37920 | — |
| FutureSearch Trials of Neurology /ID# 257186 | Austin | Texas | 78731 | — |
| FutureSearch Trials of Dallas, LP /ID# 257142 | Dallas | Texas | 75231 | — |
| Elevate Clinical - Seabrook /ID# 274679 | Houston | Texas | 77058 | — |
| Houston Clinical Research Associates /ID# 272077 | Houston | Texas | 77090 | — |
| Red Star Research, LLC /ID# 257871 | Lake Jackson | Texas | 77566 | — |
| Radiance Clinical Research /ID# 271727 | Lampasas | Texas | 76550 | — |
| Epic Clinical Research - Lewisville /ID# 274480 | Lewisville | Texas | 75057 | — |
| Sms Clinical Research /ID# 278443 | Mesquite | Texas | 75149 | — |
| Clinpoint Trials /ID# 274524 | Waxahachie | Texas | 75165 | — |
| Foothill Family Draper Clinic /ID# 277876 | Draper | Utah | 84020 | — |
| Advanced Research Institute /ID# 257853 | Ogden | Utah | 84405 | — |
| J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877 | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305 | Salt Lake City | Utah | 84121-6923 | — |
| Highland Clinical Research /ID# 257137 | Salt Lake City | Utah | 84124 | — |
| Charlottesville Medical Research /ID# 257154 | Charlottesville | Virginia | 22911 | — |
| Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851 | Norfolk | Virginia | 23502 | — |
| Northwest Clinical Research Center /ID# 257381 | Bellevue | Washington | 98007 | — |
| Puget Sound Neurology /ID# 257174 | Tacoma | Washington | 25328 | — |
| Vaught Neurological Services /ID# 267519 | Beckley | West Virginia | 25801 | — |
| West Virginia Univ School Med /ID# 258898 | Morgantown | West Virginia | 26506 | — |
| Mind+ Neurology /ID# 274486 | Mequon | Wisconsin | 53092 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06417775, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06417775 live on ClinicalTrials.gov.