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NCT04492020 | Completed | Migraine

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
Sponsor:

AbbVie

Brief Summary:

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Condition or disease

Migraine

Intervention/treatment

Ubrogepant 100mg

Placebo

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 1095 participants
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : April 19, 2022
Estimated Study Completion Date : April 19, 2022
Arm Intervention/treatment

Experimental: Treatment Sequence A

Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event

Drug: Ubrogepant 100mg

Drug: Placebo

Experimental: Treatment Sequence B

Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event

Drug: Ubrogepant 100mg

Drug: Placebo
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
  • Migraine onset before age 50 years
  • By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
  • History of 2 to 8 migraine attacks per month with moderate to severe headache in each of the 3 months prior to the Screening Visit
Exclusion Criteria
  • Difficulty distinguishing migraine headache from tension-type or other headaches
  • Participants who overuse medication for migraine defined as use of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, NSAIDs, acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
  • Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
  • A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken.
  • Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
  • Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1.
  • History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Location Details

Please Choose a site

Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

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

Not yet recruiting

United States, Alabama

Achieve Clinical Research, LLC /ID# 237098

Birmingham, Alabama, United States, 35216

Not yet recruiting

United States, Arizona

Barrow Neuro Institute /ID# 236775

Phoenix, Arizona, United States, 85013

Not yet recruiting

United States, Arkansas

Arkansas Clinical Research /ID# 238032

Little Rock, Arkansas, United States, 72205

Not yet recruiting

United States, California

California Headache and Balance Center /ID# 236247

Fresno, California, United States, 93720

Not yet recruiting

United States, California

Sun Valley Research Center /ID# 236561

Imperial, California, United States, 92251-9401

Not yet recruiting

United States, California

Wr-Pri Llc /Id# 236007

Los Alamitos, California, United States, 90720

Not yet recruiting

United States, California

Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691

Newport Beach, California, United States, 92660

Not yet recruiting

United States, California

Excell Research, Inc /ID# 237721

Oceanside, California, United States, 92056

Not yet recruiting

United States, California

George J. Rederich M.D. Inc. /ID# 235769

Torrance, California, United States, 90505

Not yet recruiting

United States, California

Diablo Clinical Research /ID# 237570

Walnut Creek, California, United States, 94598

Not yet recruiting

United States, Colorado

Colorado Springs Neurological Associates (CSNA) /ID# 236556

Colorado Springs, Colorado, United States, 80907

Not yet recruiting

United States, Colorado

Advanced Neurosciences Research, LLC /ID# 237426

Fort Collins, Colorado, United States, 80528

Not yet recruiting

United States, Florida

CNS Healthcare - Jacksonville /ID# 238245

Jacksonville, Florida, United States, 32256-6039

Not yet recruiting

United States, Florida

Health Awareness, Inc - Jupiter /ID# 236226

Jupiter, Florida, United States, 33458-7021

Not yet recruiting

United States, Florida

Suncoast Clinical Research /ID# 236934

New Port Richey, Florida, United States, 34652

Not yet recruiting

United States, Florida

Sensible Healthcare /ID# 238090

Ocoee, Florida, United States, 34761

Not yet recruiting

United States, Florida

Clinical Neuroscience Solutions, Inc /ID# 236608

Orlando, Florida, United States, 32801-2986

Not yet recruiting

United States, Florida

Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163

Saint Petersburg, Florida, United States, 33709-3113

Not yet recruiting

United States, Florida

University of South Florida /ID# 234387

Tampa, Florida, United States, 33606

Not yet recruiting

United States, Florida

ForCare Clinical Research /ID# 237092

Tampa, Florida, United States, 33613-1244

Not yet recruiting

United States, Florida

Premiere Research Institute - Palm Beach /ID# 238193

West Palm Beach, Florida, United States, 33407-3209

Not yet recruiting

United States, Georgia

NeuroTrials Research Inc. /ID# 237365

Atlanta, Georgia, United States, 30328

Not yet recruiting

United States, Georgia

iResearch Atlanta, LLC /ID# 237390

Decatur, Georgia, United States, 30030

Not yet recruiting

United States, Georgia

Meridian Clinical Research (Neurology) - Savannah /ID# 234371

Savannah, Georgia, United States, 31406-2758

Not yet recruiting

United States, Georgia

Clinical Research Atlanta - Headlands LLC /ID# 234438

Stockbridge, Georgia, United States, 30281-9054

Not yet recruiting

United States, Idaho

Northwest Clinical Trials /ID# 234968

Boise, Idaho, United States, 83704

Not yet recruiting

United States, Indiana

Deaconess Clinic Downtown /ID# 236959

Evansville, Indiana, United States, 47713-1227

Not yet recruiting

United States, Iowa

PMG Research of McFarland /ID# 238271

Ames, Iowa, United States, 50010-5733

Not yet recruiting

United States, Kansas

Collective Medical Research /ID# 236402

Overland Park, Kansas, United States, 66210

Not yet recruiting

United States, Kansas

Kansas Institute of Research /ID# 236738

Overland Park, Kansas, United States, 66211-1363

Not yet recruiting

United States, Massachusetts

Boston Clinical Trials /ID# 236559

Boston, Massachusetts, United States, 02131-2515

Not yet recruiting

United States, Michigan

Michigan Headache & Neurological Institute (MHNI) /ID# 236565

Ann Arbor, Michigan, United States, 48104-5131

Not yet recruiting

United States, Minnesota

Minneapolis Clinic of Neurology - Golden Valley /ID# 238162

Golden Valley, Minnesota, United States, 55422-4215

Not yet recruiting

United States, Minnesota

Clinical Research Institute, Inc /ID# 238301

Minneapolis, Minnesota, United States, 55402-2606

Not yet recruiting

United States, Missouri

StudyMetrix Research /ID# 236457

Saint Peters, Missouri, United States, 63303

Not yet recruiting

United States, Missouri

Clinvest Research LLC /ID# 237908

Springfield, Missouri, United States, 65807

Not yet recruiting

United States, New Jersey

Princeton Center for Clinical Research /ID# 235734

Skillman, New Jersey, United States, 08558

Not yet recruiting

United States, New Jersey

Bio Behavioral Health, Inc /ID# 238212

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

Not yet recruiting

United States, New York

Dent Neurosciences Research Center, Inc. /ID# 237039

Amherst, New York, United States, 14226

Not yet recruiting

United States, New York

Central New York Clinical Research /ID# 235694

Manlius, New York, United States, 13104

Not yet recruiting

United States, New York

Rochester Clinical Research /ID# 236842

New York, New York, United States, 14609

Not yet recruiting

United States, New York

Upstate Clinical Research Associates /ID# 238220

Williamsville, New York, United States, 14221-6046

Not yet recruiting

United States, North Carolina

PMG Research of Charlotte /ID# 237048

Charlotte, North Carolina, United States, 28209

Not yet recruiting

United States, North Carolina

Raleigh Neurology Associates /ID# 237138

Raleigh, North Carolina, United States, 27607

Not yet recruiting

United States, Ohio

CTI Clinical Research Center /ID# 237278

Cincinnati, Ohio, United States, 45212

Not yet recruiting

United States, Ohio

University of Cincinnati /ID# 234403

Cincinnati, Ohio, United States, 45267

Not yet recruiting

United States, Ohio

Aventiv Research Columbus /ID# 236837

Columbus, Ohio, United States, 43213

Not yet recruiting

United States, Oklahoma

OK Clinical Research /ID# 236675

Edmond, Oklahoma, United States, 73034-3257

Not yet recruiting

United States, Oklahoma

IPS Research Company /ID# 237674

Oklahoma City, Oklahoma, United States, 73106

Not yet recruiting

United States, Oregon

Summit Headlands LLC /ID# 236077

Portland, Oregon, United States, 97210

Not yet recruiting

United States, Pennsylvania

Abington Neurological Associates - Abington /ID# 236257

Abington, Pennsylvania, United States, 19001

Not yet recruiting

United States, Pennsylvania

Lehigh Center for Clinical Research /ID# 236703

Allentown, Pennsylvania, United States, 18104-5034

Not yet recruiting

United States, Pennsylvania

Suburban Research Associates - Media /ID# 236698

Media, Pennsylvania, United States, 19063-1760

Not yet recruiting

United States, Pennsylvania

Thomas Jefferson University Jefferson Headache Center /ID# 235821

Philadelphia, Pennsylvania, United States, 19107

Not yet recruiting

United States, Pennsylvania

Frontier Clinical Research /ID# 237924

Smithfield, Pennsylvania, United States, 15478

Not yet recruiting

United States, South Carolina

Clinical Trials of SC /ID# 237338

Charleston, South Carolina, United States, 29406

Not yet recruiting

United States, Tennessee

WR-ClinSearch /ID# 238287

Chattanooga, Tennessee, United States, 37421-1605

Not yet recruiting

United States, Tennessee

CNS Healthcare - Memphis /ID# 236396

Memphis, Tennessee, United States, 38119

Not yet recruiting

United States, Texas

FutureSearch Trials of Neurology /ID# 236428

Austin, Texas, United States, 78731

Not yet recruiting

United States, Texas

Tekton Research, Inc. /ID# 237306

Austin, Texas, United States, 78745

Not yet recruiting

United States, Texas

DiscoveResearch, Inc /ID# 236273

Bryan, Texas, United States, 77802

Not yet recruiting

United States, Texas

FutureSearch Trials of Dallas, LP /ID# 236276

Dallas, Texas, United States, 75231

Not yet recruiting

United States, Texas

Centex Studies, Inc. - Houston /ID# 237458

Houston, Texas, United States, 77058

Not yet recruiting

United States, Texas

ClinPoint Trials /ID# 236618

Waxahachie, Texas, United States, 75165-1430

Not yet recruiting

United States, Utah

Advanced Research Institute /ID# 237749

Ogden, Utah, United States, 84403

Not yet recruiting

United States, Utah

University of Utah /ID# 237602

Salt Lake City, Utah, United States, 84112-5500

Not yet recruiting

United States, Virginia

Charlottesville Medical Research /ID# 237792

Charlottesville, Virginia, United States, 22911

Not yet recruiting

United States, Virginia

Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253

Newport News, Virginia, United States, 23606

Not yet recruiting

United States, Virginia

Tidewater Integr Med Research /ID# 236867

Virginia Beach, Virginia, United States, 23451

Not yet recruiting

United States, Virginia

Sentara Neurology Specialists - Virginia Beach /ID# 234350

Virginia Beach, Virginia, United States, 23456-0019

Not yet recruiting

United States, Washington

Northwest Clinical Research Center /ID# 237585

Bellevue, Washington, United States, 98007

Not yet recruiting

United States, Washington

Seattle Clinical Research Center /ID# 236912

Seattle, Washington, United States, 98105

Not yet recruiting

United States, Washington

Puget Sound Neurology /ID# 236322

Tacoma, Washington, United States, 25328