Actively Recruiting
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Led by AbbVie · Updated on 2026-05-13
496
Participants Needed
106
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least a 1-year history of migraine with or without aura.
- Experienced migraine attacks in at least 2 of 3 perimenstrual periods during screening.
- Completed daily electronic diary data for 3 perimenstrual periods during up to 16-week screening.
- Have regular menstrual cycles between 21 and 35 days.
- Have fewer than 15 headache days per month.
- At least 70% compliance with screening and at least 3 out of 5 days of diary data in each of 3 screening perimenstrual periods.
You will not qualify if you...
- History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
- Clinically significant cardiovascular or cerebrovascular disease.
- Significant abnormalities in physical examination.
- Significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease.
- Overuse of acute headache medication.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 106 locations
1
Central Research Associates /ID# 260161
Birmingham, Alabama, United States, 35205
Completed
2
Rehabilitation & Neurological Services /ID# 275593
Huntsville, Alabama, United States, 35805
Actively Recruiting
3
MD First Research - Chandler /ID# 262564
Chandler, Arizona, United States, 85286
Actively Recruiting
4
Gilbert Neurology /ID# 260179
Gilbert, Arizona, United States, 85297
Actively Recruiting
5
Foothills Research Center/CCT Research /ID# 260180
Phoenix, Arizona, United States, 85044
Actively Recruiting
6
Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309
Tucson, Arizona, United States, 85741
Actively Recruiting
7
Preferred Research Partners /ID# 262786
Little Rock, Arkansas, United States, 72211
Actively Recruiting
8
Preferred Research Partners /ID# 273128
Little Rock, Arkansas, United States, 72211
Completed
9
Hope Clinical Research /ID# 257867
Canoga Park, California, United States, 91303
Actively Recruiting
10
Axiom Research /ID# 257833
Colton, California, United States, 92324
Actively Recruiting
11
Neuro Pain Research Center /ID# 257155
Fresno, California, United States, 93710
Actively Recruiting
12
Axiom Research, LLC-Los Angeles /ID# 264085
Glendale, California, United States, 91206
Actively Recruiting
13
Sun Valley Research Center /ID# 257152
Imperial, California, United States, 92251-9401
Actively Recruiting
14
Axiom Research - Irvine /ID# 264083
Irvine, California, United States, 92604
Actively Recruiting
15
Collaborative Neuroscience Research CNS /ID# 257828
Los Alamitos, California, United States, 90720
Completed
16
BNL Health - Los Angeles Headache Center /ID# 257237
Los Angeles, California, United States, 90067-2001
Actively Recruiting
17
M3 Wake Research - Newport Beach /ID# 257158
Newport Beach, California, United States, 92660
Actively Recruiting
18
Artemis Institute for Clinical Research - San Diego /ID# 257134
San Diego, California, United States, 92103-2204
Actively Recruiting
19
M3 Wake Research - Convoy /ID# 257897
San Diego, California, United States, 92111
Actively Recruiting
20
Optimus Medical /ID# 257856
San Francisco, California, United States, 94102
Actively Recruiting
21
New England Institute for Clinical Research /ID# 264019
Stamford, Connecticut, United States, 06905
Actively Recruiting
22
Neurology Offices of South Florida, PLLC /ID# 257161
Boca Raton, Florida, United States, 33428-2231
Actively Recruiting
23
Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
DeLand, Florida, United States, 32720
Actively Recruiting
24
Indago Research & Health Center /ID# 277943
Hialeah, Florida, United States, 33012
Actively Recruiting
25
Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
Lakeland, Florida, United States, 33803
Actively Recruiting
26
Well Pharma Medical Research /ID# 257199
Miami, Florida, United States, 33143
Actively Recruiting
27
Sensible Healthcare /ID# 257198
Ocoee, Florida, United States, 34761
Actively Recruiting
28
Clinical Neuroscience Solutions, Inc /ID# 257190
Orlando, Florida, United States, 32801-2986
Completed
29
Conquest Research /ID# 258314
Winter Park, Florida, United States, 32789
Actively Recruiting
30
NeuroTrials Research /ID# 274507
Atlanta, Georgia, United States, 30328
Actively Recruiting
31
Clinical Research Atlanta - Headlands LLC /ID# 260181
Stockbridge, Georgia, United States, 30281-9054
Actively Recruiting
32
Hawaii Pacific Neuroscience /ID# 274469
Honolulu, Hawaii, United States, 96817
Actively Recruiting
33
Velocity Clinical Research - Boise /ID# 257135
Meridian, Idaho, United States, 83642
Actively Recruiting
34
Healthcare Research Network /ID# 257868
Tinley Park, Illinois, United States, 60477
Actively Recruiting
35
Deaconess Midtown Hospital /ID# 257400
Evansville, Indiana, United States, 47710
Actively Recruiting
36
Accellacare - McFarland Clinic /ID# 257834
Ames, Iowa, United States, 50010
Actively Recruiting
37
Alliance for Multispecialty Research LLC /ID# 257839
Newton, Kansas, United States, 67114
Actively Recruiting
38
Collective Medical Research /ID# 257131
Overland Park, Kansas, United States, 66210
Actively Recruiting
39
Alliance for Multispecialty Research - Wichita East /ID# 257148
Wichita, Kansas, United States, 67207
Actively Recruiting
40
Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
Marrero, Louisiana, United States, 70072
Actively Recruiting
41
IMA Clinical Research Monroe - Wood /ID# 259362
Monroe, Louisiana, United States, 71201
Actively Recruiting
42
Headlands PharmaSite /ID# 257208
Baltimore, Maryland, United States, 21208
Actively Recruiting
43
Boston Clinical Trials /ID# 257132
Boston, Massachusetts, United States, 02131-2515
Actively Recruiting
44
BTC of New Bedford /ID# 257128
New Bedford, Massachusetts, United States, 02740
Completed
45
MedVadis Research /ID# 257156
Waltham, Massachusetts, United States, 02451
Actively Recruiting
46
Michigan Headache & Neurological Institute (MHNI) /ID# 257179
Ann Arbor, Michigan, United States, 48104-5131
Actively Recruiting
47
Memorial Healthcare Institute For Neuroscience /ID# 274663
Owosso, Michigan, United States, 48867
Actively Recruiting
48
Proven Endpoints LLC /ID# 273796
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
49
HealthCare Research Network - Hazelwood /ID# 257402
Hazelwood, Missouri, United States, 63042
Actively Recruiting
50
Clinvest Research LLC /ID# 257215
Springfield, Missouri, United States, 65807
Actively Recruiting
51
Methodist Physicians Clinic/CCT Research /ID# 260167
Fremont, Nebraska, United States, 68025
Completed
52
Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
Papillion, Nebraska, United States, 68046-4131
Actively Recruiting
53
IMA Clinical Research Las Vegas /ID# 258679
Las Vegas, Nevada, United States, 89102-1955
Completed
54
Wr-Crcn, Llc /Id# 257895
Las Vegas, Nevada, United States, 89118-2557
Actively Recruiting
55
Bio Behavioral Health, Inc /ID# 257140
Toms River, New Jersey, United States, 08755-6434
Actively Recruiting
56
IMA Clinical Research Warren /ID# 263641
Warren Township, New Jersey, United States, 07059
Actively Recruiting
57
Albuquerque Clinical Trials, Inc. /ID# 257212
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
58
Dent Neurologic Institute - Amherst /ID# 257219
Amherst, New York, United States, 14226
Actively Recruiting
59
IMA Clinical Research Westchester /ID# 259157
Hartsdale, New York, United States, 10530
Actively Recruiting
60
Fieve Clinical Research, Inc. /ID# 257177
New York, New York, United States, 10017-1921
Actively Recruiting
61
Rochester Clinical Research /ID# 257193
New York, New York, United States, 14609
Actively Recruiting
62
True North Neurology /ID# 274672
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
63
Upstate Clinical Research Associates /ID# 257163
Williamsville, New York, United States, 14221-6046
Actively Recruiting
64
Headache Wellness Center /ID# 257136
Greensboro, North Carolina, United States, 27405
Actively Recruiting
65
Accellacare - South Hawthorne Road - Winston-Salem /ID# 257731
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
66
Accellacare - South Hawthorne Road - Winston-Salem /ID# 257850
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
67
Lillestol Research, LLC /ID# 257896
Fargo, North Dakota, United States, 58104
Completed
68
CTI Clinical Research Center /ID# 257162
Cincinnati, Ohio, United States, 45212-3784
Actively Recruiting
69
C7 Research /ID# 272815
Cleveland, Ohio, United States, 44109
Actively Recruiting
70
Centricity Research Columbus /ID# 257221
Columbus, Ohio, United States, 43213
Actively Recruiting
71
Wright State Physicians Health Center /ID# 274708
Fairborn, Ohio, United States, 45324
Actively Recruiting
72
Lynn Institute of Oklahoma City /ID# 257857
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
73
Central States Research /ID# 277867
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
74
Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
Portland, Oregon, United States, 97210
Actively Recruiting
75
Abington Neurological Associates - Abington /ID# 257164
Abington, Pennsylvania, United States, 19001
Actively Recruiting
76
Clinical Research of Philadelphia, LLC /ID# 257197
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
77
Partners In Clinical Research /ID# 257855
Cumberland, Rhode Island, United States, 02864
Actively Recruiting
78
Premier Neurology /ID# 260359
Greenville, South Carolina, United States, 29605
Actively Recruiting
79
Coastal Carolina Research Center - North Charleston /ID# 257227
North Charleston, South Carolina, United States, 29405
Actively Recruiting
80
WR-ClinSearch /ID# 257160
Chattanooga, Tennessee, United States, 37421-1605
Actively Recruiting
81
KCA Neurology /ID# 274495
Franklin, Tennessee, United States, 37067
Actively Recruiting
82
Alliance for Multispecialty Research - Knoxville /ID# 257846
Knoxville, Tennessee, United States, 37920
Actively Recruiting
83
FutureSearch Trials of Neurology /ID# 257186
Austin, Texas, United States, 78731
Actively Recruiting
84
FutureSearch Trials of Dallas, LP /ID# 257142
Dallas, Texas, United States, 75231
Actively Recruiting
85
Elevate Clinical - Seabrook /ID# 274679
Houston, Texas, United States, 77058
Actively Recruiting
86
Houston Clinical Research Associates /ID# 272077
Houston, Texas, United States, 77090
Actively Recruiting
87
Red Star Research, LLC /ID# 257871
Lake Jackson, Texas, United States, 77566
Actively Recruiting
88
Radiance Clinical Research /ID# 271727
Lampasas, Texas, United States, 76550
Actively Recruiting
89
Epic Clinical Research - Lewisville /ID# 274480
Lewisville, Texas, United States, 75057
Actively Recruiting
90
Sms Clinical Research /ID# 278443
Mesquite, Texas, United States, 75149
Actively Recruiting
91
Clinpoint Trials /ID# 274524
Waxahachie, Texas, United States, 75165
Active, Not Recruiting
92
Foothill Family Draper Clinic /ID# 277876
Draper, Utah, United States, 84020
Actively Recruiting
93
Advanced Research Institute /ID# 257853
Ogden, Utah, United States, 84405
Actively Recruiting
94
J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877
Salt Lake City, Utah, United States, 84109
Actively Recruiting
95
J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
Salt Lake City, Utah, United States, 84121-6923
Actively Recruiting
96
Highland Clinical Research /ID# 257137
Salt Lake City, Utah, United States, 84124
Actively Recruiting
97
Charlottesville Medical Research /ID# 257154
Charlottesville, Virginia, United States, 22911
Actively Recruiting
98
Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
Norfolk, Virginia, United States, 23502
Actively Recruiting
99
Northwest Clinical Research Center /ID# 257381
Bellevue, Washington, United States, 98007
Actively Recruiting
100
Puget Sound Neurology /ID# 257174
Tacoma, Washington, United States, 25328
Actively Recruiting
101
Vaught Neurological Services /ID# 267519
Beckley, West Virginia, United States, 25801
Actively Recruiting
102
West Virginia Univ School Med /ID# 258898
Morgantown, West Virginia, United States, 26506
Actively Recruiting
103
Mind+ Neurology /ID# 274486
Mequon, Wisconsin, United States, 53092
Actively Recruiting
104
ISIS Clinical Research Center /ID# 262858
Guaynabo, Puerto Rico, 00969-2806
Actively Recruiting
105
Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
San Juan, Puerto Rico, 00918
Actively Recruiting
106
BDH Research /ID# 262851
San Juan, Puerto Rico, 00927
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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