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Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
Sponsor: AbbVie
Summary
Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored. Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States. All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox. 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.
Official title: A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2022-03-22
Completion Date
2025-05-02
Last Updated
2026-06-16
Healthy Volunteers
No
Conditions
Interventions
Atogepant
Oral Tablet
Locations (29)
Neurology and Neurodiagnostics of Alabama /ID# 242538
Hoover, Alabama, United States
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
Phoenix, Arizona, United States
Arkansas Clinical Research /ID# 241789
Little Rock, Arkansas, United States
Hope Clinical Research /ID# 241772
Canoga Park, California, United States
Profound Research LLC /ID# 244084
Carlsbad, California, United States
Neuro Pain Medical Center /ID# 241992
Fresno, California, United States
Neurological Research Institute /ID# 242688
Santa Monica, California, United States
Neurology Offices of South Florida, PLLC /ID# 242693
Boca Raton, Florida, United States
Coastal Clinical Research Specialists /ID# 247992
Jacksonville Beach, Florida, United States
University of Miami /ID# 252230
Miami, Florida, United States
First Physicians Group - Waldemere /ID# 242861
Sarasota, Florida, United States
Kansas Institute of Research /ID# 241796
Overland Park, Kansas, United States
Duplicate_Ochsner Clinic Foundation /ID# 241803
Covington, Louisiana, United States
Beth Israel Deaconess Medical Center /ID# 241800
Boston, Massachusetts, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 241784
Ann Arbor, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville /ID# 241994
Burnsville, Minnesota, United States
Albany Medical College /ID# 242757
Albany, New York, United States
Dent Neurologic Institute - Amherst /ID# 241776
Amherst, New York, United States
Headache Wellness Center /ID# 241791
Greensboro, North Carolina, United States
Jefferson Hospital for Neuroscience /ID# 243712
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
Uniontown, Pennsylvania, United States
Chattanooga Medical Research /ID# 253295
Chattanooga, Tennessee, United States
Nashville Neuroscience Group /ID# 243592
Nashville, Tennessee, United States
Texas Neurology /ID# 241795
Dallas, Texas, United States
Inova Health System /ID# 252242
Falls Church, Virginia, United States
Integrated Neurology Services - Falls Church /ID# 244747
Falls Church, Virginia, United States
Puget Sound Neurology /ID# 241787
Tacoma, Washington, United States
Frontier Clinical Research - Kingwood /ID# 242928
Kingwood, West Virginia, United States
West Virginia Univ School Med /ID# 252869
Morgantown, West Virginia, United States