Phase
Condition
Migraine (Pediatric)
Oral Facial Pain
Migraine (Adult)
Treatment
Atogepant
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least a 1-year history of chronic migraine (CM), with or without aura, consistentwith a diagnosis according to International Classification of Headache Disorders 3rdedition (ICHD-3 2018) and with or without acute medication overuse as defined in theprotocol.
Must be currently treated with BOTOX for CM: treated with >= 2 treatment cycles inthe 8 months prior to Visit 2 (Day 1) with documentation of payer authorization orwritten 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 20days).
Exclusion
Exclusion Criteria:
Use of opioid-containing products for more than 4 days per month for acute treatmentof headache in the 3 months prior to Screening or during the screening/baselineperiod.
Treatment of study target muscles using acupuncture, transcutaneous electrical nervestimulation (TENS), cranial traction, dental splints for headache, or head and/orneck injections of anesthetics/steroids within 4 weeks prior to Screening andthroughout the study.
Concurrent use of any migraine prevention treatment other than BOTOX (requiredconcomitant medication; or topiramate <=100mg daily) including use of oral gepantsin 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 mAbsblocking the CGRP pathway.
Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior toscreening nor during the screening/baseline period.
Study Design
Connect with a study center
Neurology and Neurodiagnostics of Alabama /ID# 242538
Hoover, Alabama 35244-5700
United StatesSite Not Available
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
Phoenix, Arizona 85013
United StatesSite Not Available
Barrow Neurological Institute /ID# 241812
Phoenix, Arizona 85013
United StatesActive - Recruiting
Arkansas Clinical Research /ID# 241789
Little Rock, Arkansas 72205
United StatesSite Not Available
Hope Clinical Research /ID# 241772
Canoga Park, California 91303
United StatesSite Not Available
North County Neurology Associates /ID# 244084
Carlsbad, California 92011-4213
United StatesActive - Recruiting
Profound Research LLC /ID# 244084
Carlsbad, California 92011-4213
United StatesSite Not Available
The Research Center of Southern California /ID# 244084
Carlsbad, California 92011-4213
United StatesActive - Recruiting
Neuro Pain Medical Center /ID# 241992
Fresno, California 93710-5473
United StatesSite Not Available
Neurological Research Institute /ID# 242688
Santa Monica, California 90404
United StatesSite Not Available
Neurology Offices of South Florida, PLLC /ID# 242693
Boca Raton, Florida 33428-2231
United StatesSite Not Available
Coastal Clinical Research Specialists /ID# 247993
Fernandina Beach, Florida 32034-4779
United StatesSite Not Available
Northwest Florida Clinical Research Group, LLC /ID# 242691
Gulf Breeze, Florida 32561-4495
United StatesSite Not Available
Coastal Clinical Research Specialists /ID# 247992
Jacksonville Beach, Florida 32250-1694
United StatesSite Not Available
University of Miami /ID# 252230
Miami, Florida 33136
United StatesSite Not Available
First Physicians Group - Waldemere /ID# 242861
Sarasota, Florida 34239-2943
United StatesSite Not Available
Robbins Headache Clinic /ID# 243618
Riverwoods, Illinois 60015-5711
United StatesSite Not Available
Kansas Institute of Research /ID# 241796
Overland Park, Kansas 66211-1363
United StatesSite Not Available
Ochsner Clinic Foundation /ID# 241803
Covington, Louisiana 70433-8107
United StatesSite Not Available
Beth Israel Deaconess Medical Center /ID# 241800
Boston, Massachusetts 02215-5400
United StatesSite Not Available
MedVadis Research /ID# 242948
Waltham, Massachusetts 02451-1105
United StatesSite Not Available
Michigan Headache & Neurological Institute (MHNI) /ID# 241784
Ann Arbor, Michigan 48104-5131
United StatesSite Not Available
Minneapolis Clinic of Neurology - Burnsville /ID# 241994
Burnsville, Minnesota 55337-6732
United StatesSite Not Available
The Headache Center /ID# 242537
Ridgeland, Mississippi 39157-2073
United StatesSite Not Available
Albany Medical College /ID# 242757
Albany, New York 12208
United StatesSite Not Available
Dent Neurosciences Research Center, Inc. /ID# 241776
Amherst, New York 14226
United StatesSite Not Available
Headache Wellness Center /ID# 241791
Greensboro, North Carolina 27405
United StatesSite Not Available
University of Cincinnati /ID# 243599
Cincinnati, Ohio 45267
United StatesSite Not Available
Jefferson Hospital for Neuroscience /ID# 243712
Philadelphia, Pennsylvania 19107-5191
United StatesSite Not Available
Frontier Clinical Research /ID# 242927
Smithfield, Pennsylvania 15478
United StatesSite Not Available
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Chattanooga Medical Research /ID# 253295
Chattanooga, Tennessee 37404-3239
United StatesSite Not Available
Nashville Neuroscience Group /ID# 243592
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Neurology /ID# 241795
Dallas, Texas 75214
United StatesSite Not Available
Inova Health System /ID# 252242
Falls Church, Virginia 22042
United StatesSite Not Available
Integrated Neurology Services - Falls Church /ID# 244747
Falls Church, Virginia 22043-2367
United StatesSite Not Available
Puget Sound Neurology /ID# 241787
Tacoma, Washington 25328
United StatesSite Not Available
Frontier Clinical Research - Kingwood /ID# 242928
Kingwood, West Virginia 26537-9797
United StatesSite Not Available
West Virginia Univ School Med /ID# 252869
Morgantown, West Virginia 26506
United StatesSite Not Available
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