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

A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

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.

Study Overview

• Status: Completed
• Conditions: Episodic Migraine
• Intervention / Treatment: Drug: Ubrogepant; Drug: Atogepant

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC /ID# 244912
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience, Inc /ID# 243506
  • California
    • Oceanside, California, United States, 92056
      • Excell Research, Inc /ID# 242590
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute /ID# 244161
    • Torrance, California, United States, 90505
      • George J. Rederich M.D. Inc. /ID# 242589
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research /ID# 242592
  • Florida
    • Jacksonville, Florida, United States, 32205-4785
      • Westside Center for Clinical Research /ID# 243287
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research /ID# 242463
    • Orlando, Florida, United States, 32810
      • Meridien Research /ID# 243508
    • Saint Petersburg, Florida, United States, 33709-3113
      • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091
  • Georgia
    • Savannah, Georgia, United States, 31406-2758
      • Meridian Clinical Research (Neurology) - Savannah /ID# 242689
    • Stockbridge, Georgia, United States, 30281-9054
      • Clinical Research Atlanta - Headlands LLC /ID# 242661
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Allied Physicians - Fort Wayne Neurological Center /ID# 243511
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc. /ID# 243505
    • Chevy Chase, Maryland, United States, 20815
      • Medstar Georgetown Neurology /ID# 243289
  • Michigan
    • Farmington Hills, Michigan, United States, 48334-2977
      • QUEST Research Institute /ID# 243284
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC /ID# 242597
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research /ID# 242652
    • Toms River, New Jersey, United States, 08755-6434
      • Bio Behavioral Health, Inc /ID# 242643
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center, Inc. /ID# 242641
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research /ID# 242593
    • New York, New York, United States, 14609
      • Rochester Clinical Research /ID# 242470
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh LLC /ID# 243286
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Trial and Consulting /ID# 242884
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Columbus /ID# 242462
    • New Albany, Ohio, United States, 43054-8167
      • The Orthopedic Foundation /ID# 243292
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network /ID# 242467
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates - Abington /ID# 243291
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421-1605
      • WR-ClinSearch /ID# 242640
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology /ID# 242690
    • Bryan, Texas, United States, 77802
      • DiscoveResearch, Inc /ID# 242469
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LP /ID# 242658
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research /ID# 244067
    • Waxahachie, Texas, United States, 75165-1430
      • ClinPoint Trials /ID# 242660
  • Utah
    • Ogden, Utah, United States, 84405-6779
      • Advanced Research Institute - Ridgeline /ID# 242662
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research /ID# 245159
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research /ID# 244436

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atogepant + Ubrogepant; Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.	Drug: Ubrogepant; Oral Tablet; Other Names: UBRELVY; Drug: Atogepant; Oral Tablet; Other Names: QULIPTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Episodic Migraine; Ubrogepant; Atogepant; QULIPTA; UBRELVY
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: M23-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No