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 450 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 Genders
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

Central Research Associates /ID# 260161
Birmingham, Alabama 35205
Contact:
Site Coordinator
(205) 327-1090

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

Gilbert Neurology Partners, PLLC/CCT Research /ID# 260179
Gilbert, Arizona 85297

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

Synexus Clinical Research US, Inc. - Tucson /ID# 258309
Tucson, Arizona 85741-3118

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

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

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

Neuro Pain Medical Center /ID# 257155
Fresno, California 93710-5473

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

Collaborative Neuroscience Research CNS /ID# 257828
Los Alamitos, California 90720

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

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

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

WR - Medical Center for Clinical Research /ID# 257897
San Diego, California 92120

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
Contact:
Site Coordinator
561-482-1027 x9

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

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

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

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

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

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

Healthcare Research Network /ID# 257868
Flossmoor, Illinois 60422
Contact:
Site Coordinator
708-388-2245

Deaconess Midtown Hospital /ID# 257400
Evansville, Indiana 47710

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

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

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

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

Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
Marrero, Louisiana 70072
Contact:
Site Coordinator
(504) 934-8424

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
Contact:
Site Coordinator
(617) 477-4868

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

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

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

Wr-Crcn, Llc /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, 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
Contact:
Site Coordinator
585-288-0890

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

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

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

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

Lillestol Research, LLC /ID# 257896
Fargo, North Dakota 58104
Contact:
Site Coordinator
701-232-7705

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

Centricity Research Columbus /ID# 257221
Columbus, Ohio 43213

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

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

Clinical Res Collaborative /ID# 257855
Cumberland, Rhode Island 02864

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

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

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

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

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

Radiance Clinical Research /ID# 271727
Lampasas, Texas 76550

Clinpoint Trials /ID# 274524
Waxahachie, Texas 75165

Advanced Research Institute /ID# 257853
Ogden, Utah 84405

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
Contact:
Site Coordinator
757-614-1001

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

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

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

BDH Research /ID# 262851
San Juan, 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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