Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine
- Registration Number
- NCT05264129
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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.
- Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant + Ubrogepant Atogepant Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks. Atogepant + Ubrogepant Ubrogepant Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks) 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.
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Up to approximately 28 weeks 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.
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator Up to approximately 24 weeks 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.
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator Up to approximately 28 weeks 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.
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 Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2 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.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 From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Advanced Research Institute - Ridgeline /ID# 242662
🇺🇸Ogden, Utah, United States
Clinvest Research LLC /ID# 242597
🇺🇸Springfield, Missouri, United States
Aventiv Research Columbus /ID# 242462
🇺🇸Columbus, Ohio, United States
Medstar Georgetown Neurology /ID# 243289
🇺🇸Chevy Chase, Maryland, United States
Xenoscience, Inc /ID# 243506
🇺🇸Phoenix, Arizona, United States
Allied Physicians - Fort Wayne Neurological Center /ID# 243511
🇺🇸Fort Wayne, Indiana, United States
Pharmasite Research, Inc. /ID# 243505
🇺🇸Baltimore, Maryland, United States
Excell Research, Inc /ID# 242590
🇺🇸Oceanside, California, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091
🇺🇸Saint Petersburg, Florida, United States
Dent Neurosciences Research Center, Inc. /ID# 242641
🇺🇸Amherst, New York, United States
PMG Research of Raleigh LLC /ID# 243286
🇺🇸Raleigh, North Carolina, United States
WR-ClinSearch /ID# 242640
🇺🇸Chattanooga, Tennessee, United States
DiscoveResearch, Inc /ID# 242469
🇺🇸Bryan, Texas, United States
Highland Clinical Research /ID# 245159
🇺🇸Salt Lake City, Utah, United States
FutureSearch Trials of Dallas, LP /ID# 242658
🇺🇸Dallas, Texas, United States
Achieve Clinical Research, LLC /ID# 244912
🇺🇸Birmingham, Alabama, United States
George J. Rederich M.D. Inc. /ID# 242589
🇺🇸Torrance, California, United States
Neurological Research Institute /ID# 244161
🇺🇸Santa Monica, California, United States
Diablo Clinical Research /ID# 242592
🇺🇸Walnut Creek, California, United States
Westside Center for Clinical Research /ID# 243287
🇺🇸Jacksonville, Florida, United States
Suncoast Clinical Research /ID# 242463
🇺🇸New Port Richey, Florida, United States
Meridian Clinical Research (Neurology) - Savannah /ID# 242689
🇺🇸Savannah, Georgia, United States
Clinical Research Atlanta - Headlands LLC /ID# 242661
🇺🇸Stockbridge, Georgia, United States
Meridien Research /ID# 243508
🇺🇸Orlando, Florida, United States
Bio Behavioral Health, Inc /ID# 242643
🇺🇸Toms River, New Jersey, United States
Princeton Center for Clinical Research /ID# 242652
🇺🇸Skillman, New Jersey, United States
CTI Clinical Trial and Consulting /ID# 242884
🇺🇸Cincinnati, Ohio, United States
Rochester Clinical Research /ID# 242470
🇺🇸New York, New York, United States
QUEST Research Institute /ID# 243284
🇺🇸Farmington Hills, Michigan, United States
Central New York Clinical Research /ID# 242593
🇺🇸Manlius, New York, United States
The Orthopedic Foundation /ID# 243292
🇺🇸New Albany, Ohio, United States
Summit Research Network /ID# 242467
🇺🇸Portland, Oregon, United States
Abington Neurological Associates - Abington /ID# 243291
🇺🇸Abington, Pennsylvania, United States
FutureSearch Trials of Neurology /ID# 242690
🇺🇸Austin, Texas, United States
Protenium Clinical Research /ID# 244067
🇺🇸Hurst, Texas, United States
ClinPoint Trials /ID# 242660
🇺🇸Waxahachie, Texas, United States
Core Clinical Research /ID# 244436
🇺🇸Everett, Washington, United States