Clinical trial NCT05264129: Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Episodic Migraine
Keywords: Episodic Migraine
Ubrogepant
Atogepant
QULIPTA
UBRELVY
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator
timeFrame: Up to approximately 28 weeks
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator
timeFrame: Up to approximately 24 weeks
measure: Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
timeFrame: Up to approximately 28 weeks
measure: 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
timeFrame: Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2
measure: 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
timeFrame: From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC /ID# 244912
state: Alabama
city: Phoenix
country: United States
facility: Xenoscience, Inc /ID# 243506
state: Arizona
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 242590
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute /ID# 244161
state: California
city: Torrance
country: United States
facility: George J. Rederich M.D. Inc. /ID# 242589
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research /ID# 242592
state: California
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research /ID# 243287
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 242463
state: Florida
city: Orlando
country: United States
facility: Meridien Research /ID# 243508
state: Florida
city: Saint Petersburg
country: United States
facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research (Neurology) - Savannah /ID# 242689
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - Headlands LLC /ID# 242661
state: Georgia
city: Fort Wayne
country: United States
facility: Allied Physicians - Fort Wayne Neurological Center /ID# 243511
state: Indiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc. /ID# 243505
state: Maryland
city: Chevy Chase
country: United States
facility: Medstar Georgetown Neurology /ID# 243289
state: Maryland
city: Farmington Hills
country: United States
facility: QUEST Research Institute /ID# 243284
state: Michigan
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 242597
state: Missouri
city: Skillman
country: United States
facility: Princeton Center for Clinical Research /ID# 242652
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health, Inc /ID# 242643
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc. /ID# 242641
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research /ID# 242593
state: New York
city: New York
country: United States
facility: Rochester Clinical Research /ID# 242470
state: New York
city: Raleigh
country: United States
facility: PMG Research of Raleigh LLC /ID# 243286
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting /ID# 242884
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Columbus /ID# 242462
state: Ohio
city: New Albany
country: United States
facility: The Orthopedic Foundation /ID# 243292
state: Ohio
city: Portland
country: United States
facility: Summit Research Network /ID# 242467
state: Oregon
city: Abington
country: United States
facility: Abington Neurological Associates - Abington /ID# 243291
state: Pennsylvania
city: Chattanooga
country: United States
facility: WR-ClinSearch /ID# 242640
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 242690
state: Texas
city: Bryan
country: United States
facility: DiscoveResearch, Inc /ID# 242469
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LP /ID# 242658
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research /ID# 244067
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials /ID# 242660
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute - Ridgeline /ID# 242662
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 245159
state: Utah
city: Everett
country: United States
facility: Core Clinical Research /ID# 244436
state: Washington
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: