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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 (TANDEM)

Primary Purpose

Episodic Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atogepant
Ubrogepant
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic Migraine, Ubrogepant, Atogepant, QULIPTA, UBRELVY

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Achieve Clinical Research, LLC /ID# 244912
  • Xenoscience, Inc /ID# 243506
  • Excell Research, Inc /ID# 242590
  • Neurological Research Institute /ID# 244161
  • George J. Rederich M.D. Inc. /ID# 242589
  • Diablo Clinical Research /ID# 242592
  • Westside Center for Clinical Research /ID# 243287
  • Suncoast Clinical Research /ID# 242463
  • Meridien Research /ID# 243508
  • Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091
  • Meridian Clinical Research (Neurology) - Savannah /ID# 242689
  • Clinical Research Atlanta - Headlands LLC /ID# 242661
  • Allied Physicians - Fort Wayne Neurological Center /ID# 243511
  • Pharmasite Research, Inc. /ID# 243505
  • Medstar Georgetown Neurology /ID# 243289
  • QUEST Research Institute /ID# 243284
  • Clinvest Research LLC /ID# 242597
  • Princeton Center for Clinical Research /ID# 242652
  • Bio Behavioral Health, Inc /ID# 242643
  • Dent Neurosciences Research Center, Inc. /ID# 242641
  • Central New York Clinical Research /ID# 242593
  • Rochester Clinical Research /ID# 242470
  • PMG Research of Raleigh LLC /ID# 243286
  • CTI Clinical Trial and Consulting /ID# 242884
  • Aventiv Research Columbus /ID# 242462
  • The Orthopedic Foundation /ID# 243292
  • Summit Research Network /ID# 242467
  • Abington Neurological Associates - Abington /ID# 243291
  • WR-ClinSearch /ID# 242640
  • FutureSearch Trials of Neurology /ID# 242690
  • DiscoveResearch, Inc /ID# 242469
  • FutureSearch Trials of Dallas, LP /ID# 242658
  • Protenium Clinical Research /ID# 244067
  • ClinPoint Trials /ID# 242660
  • Advanced Research Institute - Ridgeline /ID# 242662
  • Highland Clinical Research /ID# 245159
  • Core Clinical Research /ID# 244436

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atogepant + Ubrogepant

Arm Description

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

Outcomes

Primary Outcome Measures

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 TEAE is an AE that occurs or worsens after receiving investigational study drug.
Percentage of Participants With Clinically Significant Change in Laboratory Values as assessed by the Investigator
Percentage of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
12-lead ECGs will be recorded.
Percentage of Participants With Clinically Significant Change in Vital Sign Measurements as assessed by the Investigator
Percentage of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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).

Secondary Outcome Measures

Full Information

First Posted
February 22, 2022
Last Updated
April 5, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05264129
Brief Title
Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
Acronym
TANDEM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 EM. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine
Keywords
Episodic Migraine, Ubrogepant, Atogepant, QULIPTA, UBRELVY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atogepant + Ubrogepant
Arm Type
Experimental
Arm Description
Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Atogepant
Other Intervention Name(s)
QULIPTA
Intervention Description
Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Ubrogepant
Other Intervention Name(s)
UBRELVY
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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 TEAE is an AE that occurs or worsens after receiving investigational study drug.
Time Frame
Up to approximately 28 weeks
Title
Percentage of Participants With Clinically Significant Change in Laboratory Values as assessed by the Investigator
Description
Percentage of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Time Frame
Up to approximately 28 weeks
Title
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Description
12-lead ECGs will be recorded.
Time Frame
Up to approximately 24 weeks
Title
Percentage of Participants With Clinically Significant Change in Vital Sign Measurements as assessed by the Investigator
Description
Percentage of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Time Frame
Up to approximately 28 weeks
Title
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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).
Time Frame
Up to approximately 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC /ID# 244912
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Xenoscience, Inc /ID# 243506
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Excell Research, Inc /ID# 242590
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Neurological Research Institute /ID# 244161
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
George J. Rederich M.D. Inc. /ID# 242589
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Diablo Clinical Research /ID# 242592
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Westside Center for Clinical Research /ID# 243287
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205-4785
Country
United States
Facility Name
Suncoast Clinical Research /ID# 242463
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Meridien Research /ID# 243508
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Meridian Clinical Research (Neurology) - Savannah /ID# 242689
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2758
Country
United States
Facility Name
Clinical Research Atlanta - Headlands LLC /ID# 242661
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281-9054
Country
United States
Facility Name
Allied Physicians - Fort Wayne Neurological Center /ID# 243511
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Pharmasite Research, Inc. /ID# 243505
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Medstar Georgetown Neurology /ID# 243289
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
QUEST Research Institute /ID# 243284
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334-2977
Country
United States
Facility Name
Clinvest Research LLC /ID# 242597
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Princeton Center for Clinical Research /ID# 242652
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Bio Behavioral Health, Inc /ID# 242643
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755-6434
Country
United States
Facility Name
Dent Neurosciences Research Center, Inc. /ID# 242641
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Central New York Clinical Research /ID# 242593
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Rochester Clinical Research /ID# 242470
City
New York
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
PMG Research of Raleigh LLC /ID# 243286
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
CTI Clinical Trial and Consulting /ID# 242884
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Aventiv Research Columbus /ID# 242462
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
The Orthopedic Foundation /ID# 243292
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054-8167
Country
United States
Facility Name
Summit Research Network /ID# 242467
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Abington Neurological Associates - Abington /ID# 243291
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
WR-ClinSearch /ID# 242640
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
FutureSearch Trials of Neurology /ID# 242690
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
DiscoveResearch, Inc /ID# 242469
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
FutureSearch Trials of Dallas, LP /ID# 242658
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Protenium Clinical Research /ID# 244067
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
ClinPoint Trials /ID# 242660
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Facility Name
Advanced Research Institute - Ridgeline /ID# 242662
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405-6779
Country
United States
Facility Name
Highland Clinical Research /ID# 245159
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Core Clinical Research /ID# 244436
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
Related Info

Learn more about this trial

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

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