Status:
COMPLETED
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
Lead Sponsor:
AbbVie
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Thi...
Eligibility Criteria
Inclusion
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) (2018) and is eligible for preventive migraine treatment.
- By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
- History of at least 2 migraine attacks per month in the 2 months prior to screening.
- Sitting heart rate ≥ 45 bpm and ≤ 100 bpm during the vital signs assessment at the Screening Visit. The clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range.
- Negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the Screening Visit and Day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain).
- Must be a nonsmoker and a nonuser of nicotine-containing products (never smoked or used nicotine-containing products or has not smoked or used nicotine-containing products within the previous 2 years, including eCigarettes).
Exclusion
- Difficulty distinguishing migraine headache from tension-type or other headaches.
- Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3.
- Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3.
- Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to screening.
- Has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin).
- Clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion including, but not limited to:
- Clinically significant ischemic heart disease (eg, unstable angina pectoris).
- Clinically significant cardiac rhythm or conduction abnormalities (eg, atrial fibrillation, second- or third-degree heart block) or risk factors for torsade de pointes (eg, heart failure, hypokalemia, bradycardia).
- Myocardial infarction, transient ischemic attack, or stroke within 6 months prior to screening.
- Heart failure defined as New York Heart Association functional classification system Class III or IV.
- Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
- In the opinion of the investigator, other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or other significant neurological disorders other than migraine.
- History of malignancy in the 5 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) or previous surgery that may affect the absorption or metabolism of study interventions; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded.
- History of acute hepatitis within 6 months of screening or chronic hepatitis (including nonalcoholic steatohepatitis) or a positive result on anti-human immunodeficiency virus (HIV) type 1 and type 2 antibody, hepatitis B surface antigen (HBsAg), or anti-hepatitis C antibody testing at screening.
- Coronavirus disease 2019 (COVID-19) infection and/or COVID-19 or flu-like symptoms within 14 days of Day 1, including fever, cough, difficulty breathing.
- Close contact with anyone who has a COVID-19 infection within 14 days before Day 1.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04818515
Start Date
March 17 2021
End Date
June 18 2021
Last Update
June 16 2022
Active Locations (3)
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1
PPD Clinical Research Unit /ID# 227676
Orlando, Florida, United States, 32806-1044
2
Bio-Kinetic Clinical Applications, LLC /ID# 227675
Springfield, Missouri, United States, 65802-4842
3
Spaulding Clinical Research LLC /ID# 229505
West Bend, Wisconsin, United States, 53095