AbbVie
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 450 adult female participants with menstrual migraine will be enrolled in approximately 85 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.
Migraine
Ubrogepant
Placebo for Ubrogepant
PHASE3
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 450 participants |
Masking : | QUADRUPLE |
Primary Purpose : | TREATMENT |
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 |
Actual Study Start Date : | 2024-09-10 |
Estimated Primary Completion Date : | 2027-09-03 |
Estimated Study Completion Date : | 2027-09-08 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | FEMALE |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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Central Research Associates /ID# 260161
Birmingham, Alabama, United States, 35205
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MD First Research - Chandler /ID# 262564
Chandler, arizona, United States, 85286
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Gilbert Neurology Partners, PLLC/CCT Research /ID# 260179
Gilbert, arizona, United States, 85297
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Foothills Research Center/CCT Research /ID# 260180
Phoenix, arizona, United States, 85044
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Synexus Clinical Research US, Inc. - Tucson /ID# 258309
Tucson, arizona, United States, 85741-3118
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Hope Clinical Research /ID# 257867
Canoga Park, California, United States, 91303
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Axiom Research /ID# 257833
Colton, California, United States, 92324
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Neuro Pain Medical Center /ID# 257155
Fresno, California, United States, 93710-5473
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Sun Valley Research Center /ID# 257152
Imperial, California, United States, 92251-9401
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Axiom Research - Irvine /ID# 264083
Irvine, California, United States, 92604
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Collaborative Neuroscience Research CNS /ID# 257828
Los Alamitos, California, United States, 90720
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Los Angeles Headache Center /ID# 257237
Los Angeles, California, United States, 90067-2001
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Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158
Newport Beach, California, United States, 92660
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Artemis Institute for Clinical Research - San Diego /ID# 257134
San Diego, California, United States, 92103-2204
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WR - Medical Center for Clinical Research /ID# 257897
San Diego, California, United States, 92120
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Optimus Medical /ID# 257856
San Francisco, California, United States, 94102
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Neurology Offices of South Florida, PLLC /ID# 257161
Boca Raton, Florida, United States, 33428-2231
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Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
DeLand, Florida, United States, 32720
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Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
Lakeland, Florida, United States, 33803
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Well Pharma Medical Research /ID# 257199
Miami, Florida, United States, 33143
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Sensible Healthcare /ID# 257198
Ocoee, Florida, United States, 34761
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Clinical Neuroscience Solutions, Inc /ID# 257190
Orlando, Florida, United States, 32801-2986
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Conquest Research /ID# 258314
Winter Park, Florida, United States, 32789
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Clinical Research Atlanta - Headlands LLC /ID# 260181
Stockbridge, Georgia, United States, 30281-9054
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Healthcare Research Network /ID# 257868
Flossmoor, Illinois, United States, 60422
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Deaconess Midtown Hospital /ID# 257400
Evansville, Indiana, United States, 47710
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Accellacare - McFarland Clinic /ID# 257834
Ames, Iowa, United States, 50010
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Alliance for Multispecialty Research LLC /ID# 257839
Newton, Kansas, United States, 67114
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Collective Medical Research /ID# 257131
Overland Park, Kansas, United States, 66210
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Alliance for Multispecialty Research - Wichita East /ID# 257148
Wichita, Kansas, United States, 67207
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Tandem Clinical Research GI, LLC /ID# 260146
Marrero, Louisiana, United States, 70072
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IMA Clinical Research Monroe - Wood /ID# 259362
Monroe, Louisiana, United States, 71201
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Headlands PharmaSite /ID# 257208
Baltimore, Maryland, United States, 21208
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Boston Clinical Trials /ID# 257132
Boston, Massachusetts, United States, 02131-2515
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BTC of New Bedford /ID# 257128
New Bedford, Massachusetts, United States, 02740
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MedVadis Research /ID# 257156
Waltham, Massachusetts, United States, 02451
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Michigan Headache & Neurological Institute (MHNI) /ID# 257179
Ann Arbor, Michigan, United States, 48104-5131
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HealthCare Research Network - Hazelwood /ID# 257402
Hazelwood, Missouri, United States, 63042
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Clinvest Research LLC /ID# 257215
Springfield, Missouri, United States, 65807
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Methodist Physicians Clinic/CCT Research /ID# 260167
Fremont, Nebraska, United States, 68025
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Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
Papillion, Nebraska, United States, 68046-4131
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IMA Clinical Research Las Vegas /ID# 258679
vegas, Nevada, United States, 89102-1955
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Wr-Crcn, Llc /Id# 257895
vegas, Nevada, United States, 89118-2557
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Bio Behavioral Health, Inc /ID# 257140
Toms River, New Jersey, United States, 08755-6434
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IMA Clinical Research Warren /ID# 263641
Warren, New Jersey, United States, 07059
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Albuquerque Clinical Trials, Inc. /ID# 257212
Albuquerque, New Mexico, United States, 87102
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Dent Neurosciences Research Center, Inc. /ID# 257219
Amherst, New York, United States, 14226
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IMA Clinical Research Westchester /ID# 259157
Hartsdale, New York, United States, 10530
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Rochester Clinical Research /ID# 257193
New York, New York, United States, 14609
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Upstate Clinical Research Associates /ID# 257163
Williamsville, New York, United States, 14221-6046
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Headache Wellness Center /ID# 257136
Greensboro, North Carolina, United States, 27405
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Raleigh Medical Group /ID# 257850
Raleigh, North Carolina, United States, 27609
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Accellacare /ID# 257731
Winston-Salem, North Carolina, United States, 27103
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Lillestol Research, LLC /ID# 257896
Fargo, North Dakota, United States, 58104
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CTI Clinical Research Center /ID# 257162
Cincinnati, Ohio, United States, 45212-3784
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Centricity Research Columbus /ID# 257221
Columbus, Ohio, United States, 43213
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Lynn Institute of Oklahoma City /ID# 257857
Oklahoma City, Oklahoma, United States, 73112
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Summit Headlands LLC /ID# 257139
Portland, Oregon, United States, 97210
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Abington Neurological Associates - Abington /ID# 257164
Abington, Pennsylvania, United States, 19001
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Clinical Research of Philadelphia, LLC /ID# 257197
Philadelphia, Pennsylvania, United States, 19114
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Clinical Res Collaborative /ID# 257855
Cumberland, Rhode Island, United States, 02864
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Premier Neurology, P.C. /ID# 260359
Greer, South Carolina, United States, 29650
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Coastal Carolina Research Center - North Charleston /ID# 257227
North Charleston, South Carolina, United States, 29405
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WR-ClinSearch /ID# 257160
Chattanooga, Tennessee, United States, 37421-1605
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Alliance for Multispecialty Research - Knoxville /ID# 257846
Knoxville, Tennessee, United States, 37920
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FutureSearch Trials of Neurology /ID# 257186
Austin, Texas, United States, 78731
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FutureSearch Trials of Dallas, LP /ID# 257142
dallas, Texas, United States, 75231
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Red Star Research, LLC /ID# 257871
Lake Jackson, Texas, United States, 77566
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Advanced Research Institute /ID# 257853
Ogden, Utah, United States, 84405
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J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
Salt Lake City, Utah, United States, 84121-6923
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Highland Clinical Research /ID# 257137
Salt Lake City, Utah, United States, 84124
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Charlottesville Medical Research /ID# 257154
Charlottesville, Virginia, United States, 22911
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Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
Norfolk, Virginia, United States, 23502
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Northwest Clinical Research Center /ID# 257381
Bellevue, Washington, United States, 98007
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Puget Sound Neurology /ID# 257174
Tacoma, Washington, United States, 25328
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West Virginia Univ School Med /ID# 258898
Morgantown, West Virginia, United States, 26506