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Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

NCT ID: NCT05264129

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2023-04-04

Brief Summary

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Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine.

Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States.

Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will 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.

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Detailed Description

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Conditions

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Episodic Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atogepant + Ubrogepant

Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.

Group Type EXPERIMENTAL

Atogepant

Intervention Type DRUG

Oral Tablet

Ubrogepant

Intervention Type DRUG

Oral Tablet

Interventions

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Atogepant

Oral Tablet

Intervention Type DRUG

Ubrogepant

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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QULIPTA UBRELVY

Eligibility Criteria

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Inclusion Criteria

* At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018.
* History of 4 to 14 migraine days per month on average in the 3 months prior to Screening (Visit 1) in the investigator's judgment.

Exclusion Criteria

\- Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Achieve Clinical Research, LLC /ID# 244912

Birmingham, Alabama, United States

Site Status

Xenoscience, Inc /ID# 243506

Phoenix, Arizona, United States

Site Status

Excell Research, Inc /ID# 242590

Oceanside, California, United States

Site Status

Neurological Research Institute /ID# 244161

Santa Monica, California, United States

Site Status

George J. Rederich M.D. Inc. /ID# 242589

Torrance, California, United States

Site Status

Diablo Clinical Research /ID# 242592

Walnut Creek, California, United States

Site Status

Westside Center for Clinical Research /ID# 243287

Jacksonville, Florida, United States

Site Status

Suncoast Clinical Research /ID# 242463

New Port Richey, Florida, United States

Site Status

Meridien Research /ID# 243508

Orlando, Florida, United States

Site Status

Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091

St. Petersburg, Florida, United States

Site Status

Meridian Clinical Research (Neurology) - Savannah /ID# 242689

Savannah, Georgia, United States

Site Status

Clinical Research Atlanta - Headlands LLC /ID# 242661

Stockbridge, Georgia, United States

Site Status

Allied Physicians - Fort Wayne Neurological Center /ID# 243511

Fort Wayne, Indiana, United States

Site Status

Pharmasite Research, Inc. /ID# 243505

Baltimore, Maryland, United States

Site Status

Medstar Georgetown Neurology /ID# 243289

Chevy Chase, Maryland, United States

Site Status

QUEST Research Institute /ID# 243284

Farmington Hills, Michigan, United States

Site Status

Clinvest Research LLC /ID# 242597

Springfield, Missouri, United States

Site Status

Princeton Center for Clinical Research /ID# 242652

Skillman, New Jersey, United States

Site Status

Bio Behavioral Health, Inc /ID# 242643

Toms River, New Jersey, United States

Site Status

Dent Neurosciences Research Center, Inc. /ID# 242641

Amherst, New York, United States

Site Status

Central New York Clinical Research /ID# 242593

Manlius, New York, United States

Site Status

Rochester Clinical Research /ID# 242470

New York, New York, United States

Site Status

PMG Research of Raleigh LLC /ID# 243286

Raleigh, North Carolina, United States

Site Status

CTI Clinical Trial and Consulting /ID# 242884

Cincinnati, Ohio, United States

Site Status

Aventiv Research Columbus /ID# 242462

Columbus, Ohio, United States

Site Status

The Orthopedic Foundation /ID# 243292

New Albany, Ohio, United States

Site Status

Summit Research Network /ID# 242467

Portland, Oregon, United States

Site Status

Abington Neurological Associates - Abington /ID# 243291

Abington, Pennsylvania, United States

Site Status

WR-ClinSearch /ID# 242640

Chattanooga, Tennessee, United States

Site Status

FutureSearch Trials of Neurology /ID# 242690

Austin, Texas, United States

Site Status

DiscoveResearch, Inc /ID# 242469

Bryan, Texas, United States

Site Status

FutureSearch Trials of Dallas, LP /ID# 242658

Dallas, Texas, United States

Site Status

Protenium Clinical Research /ID# 244067

Hurst, Texas, United States

Site Status

ClinPoint Trials /ID# 242660

Waxahachie, Texas, United States

Site Status

Advanced Research Institute - Ridgeline /ID# 242662

Ogden, Utah, United States

Site Status

Highland Clinical Research /ID# 245159

Salt Lake City, Utah, United States

Site Status

Core Clinical Research /ID# 244436

Everett, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.rxabbvie.com/

Related Info

Other Identifiers

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M23-072

Identifier Type: -

Identifier Source: org_study_id

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