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

NCT05264129 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: M23-072
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Episodic Migraine

Keywords

Episodic Migraine; Ubrogepant; Atogepant; QULIPTA; UBRELVY

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Adverse Events (AEs)

  An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. A treatment-emergent adverse event (TEAE) is an AE that occurs or worsens after receiving investigational study drug.

  From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)

• Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator

  Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported.

  Up to approximately 28 weeks

• Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator

  12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  Up to approximately 24 weeks

• Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator

  PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting and standing\], pulse rate \[sitting and standing\], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.

  Up to approximately 28 weeks

• Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period

  C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.

  Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2

• Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period

  C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior.

  From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days.

Study Arms (1)

Atogepant + Ubrogepant

EXPERIMENTAL

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

Drug: Atogepant; Drug: Ubrogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: QULIPTA

Atogepant + Ubrogepant

Ubrogepant DRUG

Oral Tablet

Also known as: UBRELVY

Atogepant + Ubrogepant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (37)

Achieve Clinical Research, LLC /ID# 244912

Birmingham, Alabama, 35216, United States

Location

Xenoscience, Inc /ID# 243506

Phoenix, Arizona, 85004, United States

Location

Excell Research, Inc /ID# 242590

Oceanside, California, 92056, United States

Location

Neurological Research Institute /ID# 244161

Santa Monica, California, 90404, United States

Location

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

Torrance, California, 90505, United States

Location

Diablo Clinical Research /ID# 242592

Walnut Creek, California, 94598, United States

Location

Westside Center for Clinical Research /ID# 243287

Jacksonville, Florida, 32205-4785, United States

Location

Suncoast Clinical Research /ID# 242463

New Port Richey, Florida, 34652, United States

Location

Meridien Research /ID# 243508

Orlando, Florida, 32810, United States

Location

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

St. Petersburg, Florida, 33709-3113, United States

Location

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

Savannah, Georgia, 31406-2758, United States

Location

Clinical Research Atlanta - Headlands LLC /ID# 242661

Stockbridge, Georgia, 30281-9054, United States

Location

Allied Physicians - Fort Wayne Neurological Center /ID# 243511

Fort Wayne, Indiana, 46804, United States

Location

Pharmasite Research, Inc. /ID# 243505

Baltimore, Maryland, 21208, United States

Location

Medstar Georgetown Neurology /ID# 243289

Chevy Chase, Maryland, 20815, United States

Location

QUEST Research Institute /ID# 243284

Farmington Hills, Michigan, 48334-2977, United States

Location

Clinvest Research LLC /ID# 242597

Springfield, Missouri, 65807, United States

Location

Princeton Center for Clinical Research /ID# 242652

Skillman, New Jersey, 08558, United States

Location

Bio Behavioral Health, Inc /ID# 242643

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

Location

Dent Neurosciences Research Center, Inc. /ID# 242641

Amherst, New York, 14226, United States

Location

Central New York Clinical Research /ID# 242593

Manlius, New York, 13104, United States

Location

Rochester Clinical Research /ID# 242470

New York, New York, 14609, United States

Location

PMG Research of Raleigh LLC /ID# 243286

Raleigh, North Carolina, 27609, United States

Location

CTI Clinical Trial and Consulting /ID# 242884

Cincinnati, Ohio, 45212, United States

Location

Aventiv Research Columbus /ID# 242462

Columbus, Ohio, 43213, United States

Location

The Orthopedic Foundation /ID# 243292

New Albany, Ohio, 43054-8167, United States

Location

Summit Research Network /ID# 242467

Portland, Oregon, 97210, United States

Location

Abington Neurological Associates - Abington /ID# 243291

Abington, Pennsylvania, 19001, United States

Location

WR-ClinSearch /ID# 242640

Chattanooga, Tennessee, 37421-1605, United States

Location

FutureSearch Trials of Neurology /ID# 242690

Austin, Texas, 78731, United States

Location

DiscoveResearch, Inc /ID# 242469

Bryan, Texas, 77802, United States

Location

FutureSearch Trials of Dallas, LP /ID# 242658

Dallas, Texas, 75231, United States

Location

Protenium Clinical Research /ID# 244067

Hurst, Texas, 76054, United States

Location

ClinPoint Trials /ID# 242660

Waxahachie, Texas, 75165-1430, United States

Location

Advanced Research Institute - Ridgeline /ID# 242662

Ogden, Utah, 84405-6779, United States

Location

Highland Clinical Research /ID# 245159

Salt Lake City, Utah, 84124, United States

Location

Core Clinical Research /ID# 244436

Everett, Washington, 98201, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

atogepant; ubrogepant

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: March 7, 2022
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (37)