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

Episodic Migraine Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264129
• Other study ID #: M23-072
• Status: Completed
• Phase: Phase 4
• Start date: March 7, 2022
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Episodic Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet
• Ubrogepant
Oral Tablet

Locations

Country	Name	City	State
United States	Abington Neurological Associates - Abington /ID# 243291	Abington	Pennsylvania
United States	Dent Neurosciences Research Center, Inc. /ID# 242641	Amherst	New York
United States	FutureSearch Trials of Neurology /ID# 242690	Austin	Texas
United States	Pharmasite Research, Inc. /ID# 243505	Baltimore	Maryland
United States	Achieve Clinical Research, LLC /ID# 244912	Birmingham	Alabama
United States	DiscoveResearch, Inc /ID# 242469	Bryan	Texas
United States	WR-ClinSearch /ID# 242640	Chattanooga	Tennessee
United States	Medstar Georgetown Neurology /ID# 243289	Chevy Chase	Maryland
United States	CTI Clinical Trial and Consulting /ID# 242884	Cincinnati	Ohio
United States	Aventiv Research Columbus /ID# 242462	Columbus	Ohio
United States	FutureSearch Trials of Dallas, LP /ID# 242658	Dallas	Texas
United States	Core Clinical Research /ID# 244436	Everett	Washington
United States	QUEST Research Institute /ID# 243284	Farmington Hills	Michigan
United States	Allied Physicians - Fort Wayne Neurological Center /ID# 243511	Fort Wayne	Indiana
United States	Protenium Clinical Research /ID# 244067	Hurst	Texas
United States	Westside Center for Clinical Research /ID# 243287	Jacksonville	Florida
United States	Central New York Clinical Research /ID# 242593	Manlius	New York
United States	The Orthopedic Foundation /ID# 243292	New Albany	Ohio
United States	Suncoast Clinical Research /ID# 242463	New Port Richey	Florida
United States	Rochester Clinical Research /ID# 242470	New York	New York
United States	Excell Research, Inc /ID# 242590	Oceanside	California
United States	Advanced Research Institute - Ridgeline /ID# 242662	Ogden	Utah
United States	Meridien Research /ID# 243508	Orlando	Florida
United States	Xenoscience, Inc /ID# 243506	Phoenix	Arizona
United States	Summit Research Network /ID# 242467	Portland	Oregon
United States	PMG Research of Raleigh LLC /ID# 243286	Raleigh	North Carolina
United States	Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091	Saint Petersburg	Florida
United States	Highland Clinical Research /ID# 245159	Salt Lake City	Utah
United States	Neurological Research Institute /ID# 244161	Santa Monica	California
United States	Meridian Clinical Research (Neurology) - Savannah /ID# 242689	Savannah	Georgia
United States	Princeton Center for Clinical Research /ID# 242652	Skillman	New Jersey
United States	Clinvest Research LLC /ID# 242597	Springfield	Missouri
United States	Clinical Research Atlanta - Headlands LLC /ID# 242661	Stockbridge	Georgia
United States	Bio Behavioral Health, Inc /ID# 242643	Toms River	New Jersey
United States	George J. Rederich M.D. Inc. /ID# 242589	Torrance	California
United States	Diablo Clinical Research /ID# 242592	Walnut Creek	California
United States	ClinPoint Trials /ID# 242660	Waxahachie	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 28 weeks
Primary	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.	Up to approximately 28 weeks
Primary	Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator	12-lead ECGs will be recorded.	Up to approximately 24 weeks
Primary	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.	Up to approximately 28 weeks
Primary	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).	Up to approximately 28 weeks

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