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NCT06417775 | RECRUITING | Migraine

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

AbbVie

Brief 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 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.

Condition or disease

Migraine

Intervention/treatment

Ubrogepant

Placebo for Ubrogepant

Phase

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

Location Details

NCT06417775

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Central Research Associates /ID# 260161

Birmingham, alabama, United States, 35205

RECRUITING

United States, Arizona

MD First Research - Chandler /ID# 262564

Chandler, arizona, United States, 85286

RECRUITING

United States, Arizona

Foothills Research Center/CCT Research /ID# 260180

Phoenix, arizona, United States, 85044

RECRUITING

United States, Arizona

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

Tucson, arizona, United States, 85741-3118

RECRUITING

United States, Arkansas

Preferred Research Partners /ID# 262786

Little Rock, arkansas, United States, 72211

RECRUITING

United States, California

Hope Clinical Research /ID# 257867

Canoga Park, California, United States, 91303

RECRUITING

United States, California

Axiom Research /ID# 257833

Colton, California, United States, 92324

RECRUITING

United States, California

Neuro Pain Medical Center /ID# 257155

Fresno, California, United States, 93710-5473

RECRUITING

United States, California

Sun Valley Research Center /ID# 257152

Imperial, California, United States, 92251-9401

RECRUITING

United States, California

Axiom Research - Irvine /ID# 264083

Irvine, California, United States, 92604

RECRUITING

United States, California

Collaborative Neuroscience Research CNS /ID# 257828

Los Alamitos, California, United States, 90720

RECRUITING

United States, California

Los Angeles Headache Center /ID# 257237

Los Angeles, California, United States, 90067-2001

RECRUITING

United States, California

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

Newport Beach, California, United States, 92660

RECRUITING

United States, California

Artemis Institute for Clinical Research - San Diego /ID# 257134

San Diego, California, United States, 92103-2204

RECRUITING

United States, California

WR - Medical Center for Clinical Research /ID# 257897

San Diego, California, United States, 92120

RECRUITING

United States, California

Optimus Medical /ID# 257856

San Francisco, California, United States, 94102

RECRUITING

United States, Florida

Neurology Offices of South Florida, PLLC /ID# 257161

Boca Raton, florida, United States, 33428-2231

RECRUITING

United States, Florida

Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403

DeLand, florida, United States, 32720

RECRUITING

United States, Florida

Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874

Lakeland, florida, United States, 33803

RECRUITING

United States, Florida

Well Pharma Medical Research /ID# 257199

Miami, florida, United States, 33143

RECRUITING

United States, Florida

Sensible Healthcare /ID# 257198

Ocoee, florida, United States, 34761

RECRUITING

United States, Florida

Clinical Neuroscience Solutions, Inc /ID# 257190

Orlando, florida, United States, 32801-2986

RECRUITING

United States, Florida

Conquest Research /ID# 258314

Winter Park, florida, United States, 32789

RECRUITING

United States, Georgia

Clinical Research Atlanta - Headlands LLC /ID# 260181

Stockbridge, Georgia, United States, 30281-9054

RECRUITING

United States, Idaho

Velocity Clinical Research - Boise /ID# 257135

Meridian, Idaho, United States, 83642

RECRUITING

United States, Illinois

Healthcare Research Network /ID# 257868

Flossmoor, Illinois, United States, 60422

RECRUITING

United States, Indiana

Deaconess Midtown Hospital /ID# 257400

Evansville, Indiana, United States, 47710

RECRUITING

United States, Iowa

Accellacare - McFarland Clinic /ID# 257834

Ames, Iowa, United States, 50010

RECRUITING

United States, Kansas

Alliance for Multispecialty Research LLC /ID# 257839

Newton, Kansas, United States, 67114

RECRUITING

United States, Kansas

Collective Medical Research /ID# 257131

Overland Park, Kansas, United States, 66210

RECRUITING

United States, Kansas

Alliance for Multispecialty Research - Wichita East /ID# 257148

Wichita, Kansas, United States, 67207

RECRUITING

United States, Louisiana

Tandem Clinical Research GI, LLC /ID# 260146

Marrero, Louisiana, United States, 70072

RECRUITING

United States, Louisiana

IMA Clinical Research Monroe - Wood /ID# 259362

Monroe, Louisiana, United States, 71201

RECRUITING

United States, Maryland

Headlands PharmaSite /ID# 257208

Baltimore, Maryland, United States, 21208

RECRUITING

United States, Massachusetts

Boston Clinical Trials /ID# 257132

Boston, Massachusetts, United States, 02131-2515

RECRUITING

United States, Massachusetts

BTC of New Bedford /ID# 257128

New Bedford, Massachusetts, United States, 02740

RECRUITING

United States, Massachusetts

MedVadis Research /ID# 257156

Waltham, Massachusetts, United States, 02451

RECRUITING

United States, road cancer

Michigan Headache & Neurological Institute (MHNI) /ID# 257179

Ann Arbor, road cancer, United States, 48104-5131

RECRUITING

United States, Missouri

HealthCare Research Network - Hazelwood /ID# 257402

Hazelwood, Missouri, United States, 63042

RECRUITING

United States, Missouri

Clinvest Research LLC /ID# 257215

Springfield, Missouri, United States, 65807

RECRUITING

United States, Nebraska

Methodist Physicians Clinic/CCT Research /ID# 260167

Fremont, Nebraska, United States, 68025

RECRUITING

United States, Nebraska

Cognitive Clinical Trials (CCT) - Papillion /ID# 260174

Papillion, Nebraska, United States, 68046-4131

COMPLETED

United States, Nevada

IMA Clinical Research Las Vegas /ID# 258679

vegas, Nevada, United States, 89102-1955

RECRUITING

United States, Nevada

Wr-Crcn, Llc /Id# 257895

vegas, Nevada, United States, 89118-2557

RECRUITING

United States, New Jersey

Bio Behavioral Health, Inc /ID# 257140

Toms River, New Jersey, United States, 08755-6434

RECRUITING

United States, New Jersey

IMA Clinical Research Warren /ID# 263641

Warren, New Jersey, United States, 07059

RECRUITING

United States, New Mexico

Albuquerque Clinical Trials, Inc. /ID# 257212

Albuquerque, New Mexico, United States, 87102

RECRUITING

United States, New York

Dent Neurosciences Research Center, Inc. /ID# 257219

Amherst, New York, United States, 14226

RECRUITING

United States, New York

IMA Clinical Research Westchester /ID# 259157

Hartsdale, New York, United States, 10530

RECRUITING

United States, New York

Fieve Clinical Research, Inc. /ID# 257177

New York, New York, United States, 10017-1921

RECRUITING

United States, New York

Rochester Clinical Research /ID# 257193

New York, New York, United States, 14609

RECRUITING

United States, New York

Upstate Clinical Research Associates /ID# 257163

Williamsville, New York, United States, 14221-6046

RECRUITING

United States, North Carolina

Headache Wellness Center /ID# 257136

Greensboro, North Carolina, United States, 27405

RECRUITING

United States, North Carolina

Raleigh Medical Group /ID# 257850

Raleigh, North Carolina, United States, 27609

RECRUITING

United States, North Carolina

Accellacare /ID# 257731

Winston-Salem, North Carolina, United States, 27103

RECRUITING

United States, North Dakota

Lillestol Research, LLC /ID# 257896

Fargo, North Dakota, United States, 58104

RECRUITING

United States, Ohio

CTI Clinical Research Center /ID# 257162

Cincinnati, Ohio, United States, 45212-3784

RECRUITING

United States, Ohio

Centricity Research Columbus /ID# 257221

Columbus, Ohio, United States, 43213

RECRUITING

United States, Oklahoma

Lynn Institute of Oklahoma City /ID# 257857

Oklahoma City, Oklahoma, United States, 73112

RECRUITING

United States, Oregon

Summit Headlands LLC /ID# 257139

Portland, Oregon, United States, 97210

RECRUITING

United States, Pennsylvania

Abington Neurological Associates - Abington /ID# 257164

Abington, Pennsylvania, United States, 19001

RECRUITING

United States, Pennsylvania

Clinical Research of Philadelphia, LLC /ID# 257197

Philadelphia, Pennsylvania, United States, 19114

RECRUITING

United States, Rhode Island

Clinical Res Collaborative /ID# 257855

Cumberland, Rhode Island, United States, 02864

RECRUITING

United States, South Carolina

Premier Neurology, P.C. /ID# 260359

Greer, South Carolina, United States, 29650

RECRUITING

United States, South Carolina

Coastal Carolina Research Center - North Charleston /ID# 257227

North Charleston, South Carolina, United States, 29405

RECRUITING

United States, Tennessee

WR-ClinSearch /ID# 257160

Chattanooga, Tennessee, United States, 37421-1605

RECRUITING

United States, Tennessee

Alliance for Multispecialty Research - Knoxville /ID# 257846

Knoxville, Tennessee, United States, 37920

RECRUITING

United States, Texas

FutureSearch Trials of Neurology /ID# 257186

Austin, Texas, United States, 78731

RECRUITING

United States, Texas

FutureSearch Trials of Dallas, LP /ID# 257142

dallas, Texas, United States, 75231

RECRUITING

United States, Texas

Red Star Research, LLC /ID# 257871

Lake Jackson, Texas, United States, 77566

RECRUITING

United States, Utah

Advanced Research Institute /ID# 257853

Ogden, Utah, United States, 84405

RECRUITING

United States, Utah

J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305

Salt Lake City, Utah, United States, 84121-6923

RECRUITING

United States, Utah

Highland Clinical Research /ID# 257137

Salt Lake City, Utah, United States, 84124

RECRUITING

United States, Virginia

Charlottesville Medical Research /ID# 257154

Charlottesville, Virginia, United States, 22911

RECRUITING

United States, Virginia

Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851

Norfolk, Virginia, United States, 23502

RECRUITING

United States, Washington

Northwest Clinical Research Center /ID# 257381

Bellevue, Washington, United States, 98007

RECRUITING

United States, Washington

Puget Sound Neurology /ID# 257174

tacoma, Washington, United States, 25328

RECRUITING

United States, West Virginia

West Virginia Univ School Med /ID# 258898

Morgantown, West Virginia, United States, 26506