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Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Sponsor: AbbVie
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
496
Start Date
2024-09-10
Completion Date
2027-09
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
Ubrogepant
Oral Tablets
Placebo for Ubrogepant
Oral Tablets
Locations (106)
Central Research Associates /ID# 260161
Birmingham, Alabama, United States
Rehabilitation & Neurological Services /ID# 275593
Huntsville, Alabama, United States
MD First Research - Chandler /ID# 262564
Chandler, Arizona, United States
Gilbert Neurology /ID# 260179
Gilbert, Arizona, United States
Foothills Research Center/CCT Research /ID# 260180
Phoenix, Arizona, United States
Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309
Tucson, Arizona, United States
Preferred Research Partners /ID# 262786
Little Rock, Arkansas, United States
Preferred Research Partners /ID# 273128
Little Rock, Arkansas, United States
Hope Clinical Research /ID# 257867
Canoga Park, California, United States
Axiom Research /ID# 257833
Colton, California, United States
Neuro Pain Medical Center /ID# 257155
Fresno, California, United States
Axiom Research, LLC-Los Angeles /ID# 264085
Glendale, California, United States
Sun Valley Research Center /ID# 257152
Imperial, California, United States
Axiom Research - Irvine /ID# 264083
Irvine, California, United States
Collaborative Neuroscience Research CNS /ID# 257828
Los Alamitos, California, United States
Los Angeles Headache Center /ID# 257237
Los Angeles, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158
Newport Beach, California, United States
Artemis Institute for Clinical Research - San Diego /ID# 257134
San Diego, California, United States
M3 Wake Research - Convoy /ID# 257897
San Diego, California, United States
Optimus Medical /ID# 257856
San Francisco, California, United States
New England Institute for Clinical Research /ID# 264019
Stamford, Connecticut, United States
Neurology Offices of South Florida, PLLC /ID# 257161
Boca Raton, Florida, United States
Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
DeLand, Florida, United States
Indago Research & Health Center /ID# 277943
Hialeah, Florida, United States
Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
Lakeland, Florida, United States
Well Pharma Medical Research /ID# 257199
Miami, Florida, United States
Sensible Healthcare /ID# 257198
Ocoee, Florida, United States
Clinical Neuroscience Solutions, Inc /ID# 257190
Orlando, Florida, United States
Conquest Research /ID# 258314
Winter Park, Florida, United States
NeuroTrials Research /ID# 274507
Atlanta, Georgia, United States
Clinical Research Atlanta - Headlands LLC /ID# 260181
Stockbridge, Georgia, United States
Hawaii Pacific Neuroscience /ID# 274469
Honolulu, Hawaii, United States
Velocity Clinical Research - Boise /ID# 257135
Meridian, Idaho, United States
Healthcare Research Network /ID# 257868
Tinley Park, Illinois, United States
Deaconess Midtown Hospital /ID# 257400
Evansville, Indiana, United States
Accellacare - McFarland Clinic /ID# 257834
Ames, Iowa, United States
Alliance for Multispecialty Research LLC /ID# 257839
Newton, Kansas, United States
Collective Medical Research /ID# 257131
Overland Park, Kansas, United States
Alliance for Multispecialty Research - Wichita East /ID# 257148
Wichita, Kansas, United States
Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
Marrero, Louisiana, United States
IMA Clinical Research Monroe - Wood /ID# 259362
Monroe, Louisiana, United States
Headlands PharmaSite /ID# 257208
Baltimore, Maryland, United States
Boston Clinical Trials /ID# 257132
Boston, Massachusetts, United States
BTC of New Bedford /ID# 257128
New Bedford, Massachusetts, United States
MedVadis Research /ID# 257156
Waltham, Massachusetts, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 257179
Ann Arbor, Michigan, United States
Memorial Healthcare Institute For Neuroscience /ID# 274663
Owosso, Michigan, United States
Proven Endpoints LLC /ID# 273796
Ridgeland, Mississippi, United States
HealthCare Research Network - Hazelwood /ID# 257402
Hazelwood, Missouri, United States
Clinvest Research LLC /ID# 257215
Springfield, Missouri, United States
Methodist Physicians Clinic/CCT Research /ID# 260167
Fremont, Nebraska, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
Papillion, Nebraska, United States
IMA Clinical Research Las Vegas /ID# 258679
Las Vegas, Nevada, United States
Wr-Crcn, Llc /Id# 257895
Las Vegas, Nevada, United States
Bio Behavioral Health, Inc /ID# 257140
Toms River, New Jersey, United States
IMA Clinical Research Warren /ID# 263641
Warren Township, New Jersey, United States
Albuquerque Clinical Trials, Inc. /ID# 257212
Albuquerque, New Mexico, United States
Dent Neurologic Institute - Amherst /ID# 257219
Amherst, New York, United States
IMA Clinical Research Westchester /ID# 259157
Hartsdale, New York, United States
Fieve Clinical Research, Inc. /ID# 257177
New York, New York, United States
Rochester Clinical Research /ID# 257193
New York, New York, United States
True North Neurology /ID# 274672
Port Jefferson Station, New York, United States
Upstate Clinical Research Associates /ID# 257163
Williamsville, New York, United States
Headache Wellness Center /ID# 257136
Greensboro, North Carolina, United States
Accellacare /ID# 257731
Winston-Salem, North Carolina, United States
Accellacare /ID# 257850
Winston-Salem, North Carolina, United States
Lillestol Research, LLC /ID# 257896
Fargo, North Dakota, United States
CTI Clinical Research Center /ID# 257162
Cincinnati, Ohio, United States
C7 Research /ID# 272815
Cleveland, Ohio, United States
Centricity Research Columbus /ID# 257221
Columbus, Ohio, United States
Wright State Physicians Health Center /ID# 274708
Fairborn, Ohio, United States
Lynn Institute of Oklahoma City /ID# 257857
Oklahoma City, Oklahoma, United States
Central States Research /ID# 277867
Tulsa, Oklahoma, United States
Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
Portland, Oregon, United States
Abington Neurological Associates - Abington /ID# 257164
Abington, Pennsylvania, United States
Clinical Research of Philadelphia, LLC /ID# 257197
Philadelphia, Pennsylvania, United States
Partners In Clinical Research /ID# 257855
Cumberland, Rhode Island, United States
Premier Neurology /ID# 260359
Greenville, South Carolina, United States
Coastal Carolina Research Center - North Charleston /ID# 257227
North Charleston, South Carolina, United States
WR-ClinSearch /ID# 257160
Chattanooga, Tennessee, United States
KCA Neurology /ID# 274495
Franklin, Tennessee, United States
Alliance for Multispecialty Research - Knoxville /ID# 257846
Knoxville, Tennessee, United States
FutureSearch Trials of Neurology /ID# 257186
Austin, Texas, United States
FutureSearch Trials of Dallas, LP /ID# 257142
Dallas, Texas, United States
Elevate Clinical - Seabrook /ID# 274679
Houston, Texas, United States
Houston Clinical Research Associates /ID# 272077
Houston, Texas, United States
Red Star Research, LLC /ID# 257871
Lake Jackson, Texas, United States
Radiance Clinical Research /ID# 271727
Lampasas, Texas, United States
Epic Clinical Research - Lewisville /ID# 274480
Lewisville, Texas, United States
Sms Clinical Research /ID# 278443
Mesquite, Texas, United States
Clinpoint Trials /ID# 274524
Waxahachie, Texas, United States
Foothill Family Draper Clinic /ID# 277876
Draper, Utah, United States
Advanced Research Institute /ID# 257853
Ogden, Utah, United States
J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
Salt Lake City, Utah, United States
Highland Clinical Research /ID# 257137
Salt Lake City, Utah, United States
Charlottesville Medical Research /ID# 257154
Charlottesville, Virginia, United States
Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
Norfolk, Virginia, United States
Northwest Clinical Research Center /ID# 257381
Bellevue, Washington, United States
Puget Sound Neurology /ID# 257174
Tacoma, Washington, United States
Vaught Neurological Services /ID# 267519
Beckley, West Virginia, United States
West Virginia Univ School Med /ID# 258898
Morgantown, West Virginia, United States
Mind+ Neurology /ID# 274486
Mequon, Wisconsin, United States
ISIS Clinical Research Center /ID# 262858
Guaynabo, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
San Juan, Puerto Rico
BDH Research /ID# 262851
San Juan, Puerto Rico