Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine

Purpose

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.

Condition

  • Migraine

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least a 1-year history of migraine with or without aura. - Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period. - Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis. - Have regular menstrual cycles of between 21-35 days in length. - Less than 15 headache days per month. - At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria

  • History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine. - Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion. - Clinically significant abnormalities in the physical examination as determined by the investigator. - Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion. - Acute headache medication overuse.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Double-Blind Period: Ubrogepant 		Participants will receive ubrogepant during the double-blind period.
  • Drug: Ubrogepant
    Oral Tablets
    Other names:
    • UBRELVY
Experimental
Double-Blind Period: Placebo for Ubrogepant 		Participants will receive placebo during the double-blind period.
  • Drug: Placebo for Ubrogepant
    Oral Tablets
Experimental
Open-Label Extension Period: Ubrogepant 		Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
  • Drug: Ubrogepant
    Oral Tablets
    Other names:
    • UBRELVY

Recruiting Locations

Rehabilitation & Neurological Services /ID# 275593
Huntsville 4068590, Alabama 4829764 35805

MD First Research - Chandler /ID# 262564
Chandler 5289282, Arizona 5551752 85286

Gilbert Neurology /ID# 260179
Gilbert 5295903, Arizona 5551752 85297

Foothills Research Center/CCT Research /ID# 260180
Phoenix 5308655, Arizona 5551752 85044

Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309
Tucson 5318313, Arizona 5551752 85741

Preferred Research Partners /ID# 262786
Little Rock 4119403, Arkansas 4099753 72211

Hope Clinical Research /ID# 257867
Canoga Park 5333913, California 5332921 91303

Axiom Research /ID# 257833
Colton 5338783, California 5332921 92324
Contact:
Site Coordinator
909-824-2325

Neuro Pain Medical Center /ID# 257155
Fresno 5350937, California 5332921 93710

Axiom Research, LLC-Los Angeles /ID# 264085
Glendale 5352423, California 5332921 91206

Sun Valley Research Center /ID# 257152
Imperial 5359052, California 5332921 92251-9401

Axiom Research - Irvine /ID# 264083
Irvine 5359777, California 5332921 92604

Los Angeles Headache Center /ID# 257237
Los Angeles 5368361, California 5332921 90067-2001
Contact:
Site Coordinator
(310) 277-9534

Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158
Newport Beach 5376890, California 5332921 92660

Artemis Institute for Clinical Research - San Diego /ID# 257134
San Diego 5391811, California 5332921 92103-2204

M3 Wake Research - Convoy /ID# 257897
San Diego 5391811, California 5332921 92111

Optimus Medical /ID# 257856
San Francisco 5391959, California 5332921 94102

New England Institute for Clinical Research /ID# 264019
Stamford 4843564, Connecticut 4831725 06905

Neurology Offices of South Florida, PLLC /ID# 257161
Boca Raton 4148411, Florida 4155751 33428-2231
Contact:
Site Coordinator
561-482-1027 x9

Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
DeLand 4152890, Florida 4155751 32720
Contact:
Site Coordinator
386-785-2400

Indago Research & Health Center /ID# 277943
Hialeah 4158476, Florida 4155751 33012
Contact:
Site Coordinator
305-825-6588

Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
Lakeland 4161438, Florida 4155751 33803
Contact:
Site Coordinator
863-940-2087

Well Pharma Medical Research /ID# 257199
Miami 4164138, Florida 4155751 33143

Sensible Healthcare /ID# 257198
Ocoee 4166776, Florida 4155751 34761

Conquest Research /ID# 258314
Winter Park 4178560, Florida 4155751 32789

NeuroTrials Research /ID# 274507
Atlanta 4180439, Georgia 4197000 30328

Clinical Research Atlanta - Headlands LLC /ID# 260181
Stockbridge 4224681, Georgia 4197000 30281-9054

Hawaii Pacific Neuroscience /ID# 274469
Honolulu 5856195, Hawaii 5855797 96817

Velocity Clinical Research - Boise /ID# 257135
Meridian 5600685, Idaho 5596512 83642

Healthcare Research Network /ID# 257868
Tinley Park 4913723, Illinois 4896861 60477
Contact:
Site Coordinator
708-388-2245

Deaconess Midtown Hospital /ID# 257400
Evansville 4257227, Indiana 4921868 47710

Accellacare - McFarland Clinic /ID# 257834
Ames 4846834, Iowa 4862182 50010
Contact:
Site Coordinator
515-956-4159

Alliance for Multispecialty Research LLC /ID# 257839
Newton 4276248, Kansas 4273857 67114

Collective Medical Research /ID# 257131
Overland Park 4276873, Kansas 4273857 66210
Contact:
Site Coordinator
(913) 381-7180

Alliance for Multispecialty Research - Wichita East /ID# 257148
Wichita 4281730, Kansas 4273857 67207

Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
Marrero 4332628, Louisiana 4331987 70072

IMA Clinical Research Monroe - Wood /ID# 259362
Monroe 4333669, Louisiana 4331987 71201

Headlands PharmaSite /ID# 257208
Baltimore 4347778, Maryland 4361885 21208

Boston Clinical Trials /ID# 257132
Boston 4930956, Massachusetts 6254926 02131-2515
Contact:
Site Coordinator
(617) 477-4868

MedVadis Research /ID# 257156
Waltham 4954380, Massachusetts 6254926 02451

Michigan Headache & Neurological Institute (MHNI) /ID# 257179
Ann Arbor 4984247, Michigan 5001836 48104-5131

Memorial Healthcare Institute For Neuroscience /ID# 274663
Owosso 5004792, Michigan 5001836 48867

Proven Endpoints LLC /ID# 273796
Ridgeland 4443296, Mississippi 4436296 39157

HealthCare Research Network - Hazelwood /ID# 257402
Hazelwood 4389967, Missouri 4398678 63042
Contact:
Site Coordinator
314-972-9600

Clinvest Research LLC /ID# 257215
Springfield 4409896, Missouri 4398678 65807

Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
Papillion 5074792, Nebraska 5073708 68046-4131

Wr-Crcn, Llc /Id# 257895
Las Vegas 5506956, Nevada 5509151 89118-2557

Bio Behavioral Health, Inc /ID# 257140
Toms River 4504476, New Jersey 5101760 08755-6434

IMA Clinical Research Warren /ID# 263641
Warren Township 8299577, New Jersey 5101760 07059

Albuquerque Clinical Trials, Inc. /ID# 257212
Albuquerque 5454711, New Mexico 5481136 87102

Dent Neurologic Institute - Amherst /ID# 257219
Amherst 5107129, New York 5128638 14226

IMA Clinical Research Westchester /ID# 259157
Hartsdale 5120141, New York 5128638 10530

Fieve Clinical Research, Inc. /ID# 257177
New York 5128581, New York 5128638 10017-1921

Rochester Clinical Research /ID# 257193
New York 5128581, New York 5128638 14609
Contact:
Site Coordinator
585-288-0890

True North Neurology /ID# 274672
Port Jefferson Station 5132015, New York 5128638 11776

Upstate Clinical Research Associates /ID# 257163
Williamsville 5144588, New York 5128638 14221-6046

Headache Wellness Center /ID# 257136
Greensboro 4469146, North Carolina 4482348 27405

Accellacare /ID# 257731
Winston-Salem 4499612, North Carolina 4482348 27103

Accellacare /ID# 257850
Winston-Salem 4499612, North Carolina 4482348 27103

CTI Clinical Research Center /ID# 257162
Cincinnati 4508722, Ohio 5165418 45212-3784

C7 Research /ID# 272815
Cleveland 5150529, Ohio 5165418 44109
Contact:
Site Coordinator
216-856-1655

Centricity Research Columbus /ID# 257221
Columbus 4509177, Ohio 5165418 43213

Wright State Physicians Health Center /ID# 274708
Fairborn 4511263, Ohio 5165418 45324

Lynn Institute of Oklahoma City /ID# 257857
Oklahoma City 4544349, Oklahoma 4544379 73112
Contact:
Site Coordinator
405.447.8839

Central States Research /ID# 277867
Tulsa 4553433, Oklahoma 4544379 74136

Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
Portland 5746545, Oregon 5744337 97210

Abington Neurological Associates - Abington /ID# 257164
Abington 5177773, Pennsylvania 6254927 19001

Clinical Research of Philadelphia, LLC /ID# 257197
Philadelphia 4560349, Pennsylvania 6254927 19114

Partners In Clinical Research /ID# 257855
Cumberland 5221703, Rhode Island 5224323 02864

Premier Neurology /ID# 260359
Greenville 4580543, South Carolina 4597040 29605
Contact:
Site Coordinator
864-655-4005 x113

Coastal Carolina Research Center - North Charleston /ID# 257227
North Charleston 4589387, South Carolina 4597040 29405

WR-ClinSearch /ID# 257160
Chattanooga 4612862, Tennessee 4662168 37421-1605

KCA Neurology /ID# 274495
Franklin 4623560, Tennessee 4662168 37067

Alliance for Multispecialty Research - Knoxville /ID# 257846
Knoxville 4634946, Tennessee 4662168 37920

FutureSearch Trials of Neurology /ID# 257186
Austin 4671654, Texas 4736286 78731

FutureSearch Trials of Dallas, LP /ID# 257142
Dallas 4684888, Texas 4736286 75231

Elevate Clinical - Seabrook /ID# 274679
Houston 4699066, Texas 4736286 77058

Houston Clinical Research Associates /ID# 272077
Houston 4699066, Texas 4736286 77090
Contact:
Site Coordinator
1-833-300-2677

Red Star Research, LLC /ID# 257871
Lake Jackson 4704628, Texas 4736286 77566

Radiance Clinical Research /ID# 271727
Lampasas 4705176, Texas 4736286 76550

Epic Clinical Research - Lewisville /ID# 274480
Lewisville 4706057, Texas 4736286 75057

Sms Clinical Research /ID# 278443
Mesquite 4710826, Texas 4736286 75149

Clinpoint Trials /ID# 274524
Waxahachie 4740328, Texas 4736286 75165

Foothill Family Draper Clinic /ID# 277876
Draper 5774001, Utah 5549030 84020

Advanced Research Institute /ID# 257853
Ogden 5779206, Utah 5549030 84405

J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877
Salt Lake City 5780993, Utah 5549030 84109

J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
Salt Lake City 5780993, Utah 5549030 84121-6923

Highland Clinical Research /ID# 257137
Salt Lake City 5780993, Utah 5549030 84124

Charlottesville Medical Research /ID# 257154
Charlottesville 4752031, Virginia 6254928 22911

Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
Norfolk 4776222, Virginia 6254928 23502
Contact:
Site Coordinator
757-614-1001

Northwest Clinical Research Center /ID# 257381
Bellevue 5786882, Washington 5815135 98007

Puget Sound Neurology /ID# 257174
Tacoma 5812944, Washington 5815135 25328

Vaught Neurological Services /ID# 267519
Beckley 4798308, West Virginia 4826850 25801

West Virginia Univ School Med /ID# 258898
Morgantown 4815352, West Virginia 4826850 26506

Mind+ Neurology /ID# 274486
Mequon 5262649, Wisconsin 5279468 53092

ISIS Clinical Research Center /ID# 262858
Guaynabo 4565119, Puerto Rico 00969-2806

Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
San Juan 4568127, Puerto Rico 00918

BDH Research /ID# 262851
San Juan 4568127, Puerto Rico 00927

More Details

NCT ID
NCT06417775
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

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