Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
NCT ID: NCT05216263
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2022-03-22
2025-05-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atogepant
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
Atogepant
Oral Tablet
Interventions
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Atogepant
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be currently treated with BOTOX for CM: treated with \>= 2 treatment cycles in the 8 months prior to Visit 2 (Day 1) with documentation of payer authorization or written attestation of self-pay to support continued use of BOTOX.
* Must have 8 to 23 (inclusive) migraine days in the electronic diary \[eDiary\] screening/baseline period (eDiary data must have been collected for at least 20 days).
Exclusion Criteria
* Treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to Screening and throughout the study.
* Concurrent use of any migraine prevention treatment other than BOTOX (required concomitant medication; or topiramate \<=100mg daily) including use of oral gepants in the 4 weeks prior to screening nor during the screening/baseline period.
* Current use or use within the 6 months (24 weeks) prior to Screening, of mAbs blocking the CGRP pathway.
* Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to screening nor during the screening/baseline period.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
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
Countries
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Related Links
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Other Identifiers
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M22-418
Identifier Type: -
Identifier Source: org_study_id
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