Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Last updated: October 31, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

3

Condition

Migraine (Pediatric)

Oral Facial Pain

Migraine (Adult)

Treatment

Atogepant

Clinical Study ID

NCT05216263
M22-418
  • Ages 18-75
  • All Genders

Study 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.

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

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: Atogepant
Phase: 3
Study Start date:
March 22, 2022
Estimated Completion Date:
April 04, 2025

Connect with a study center

  • Neurology and Neurodiagnostics of Alabama /ID# 242538

    Hoover, Alabama 35244-5700
    United States

    Site Not Available

  • Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Barrow Neurological Institute /ID# 241812

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Arkansas Clinical Research /ID# 241789

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Hope Clinical Research /ID# 241772

    Canoga Park, California 91303
    United States

    Site Not Available

  • North County Neurology Associates /ID# 244084

    Carlsbad, California 92011-4213
    United States

    Active - Recruiting

  • Profound Research LLC /ID# 244084

    Carlsbad, California 92011-4213
    United States

    Site Not Available

  • The Research Center of Southern California /ID# 244084

    Carlsbad, California 92011-4213
    United States

    Active - Recruiting

  • Neuro Pain Medical Center /ID# 241992

    Fresno, California 93710-5473
    United States

    Site Not Available

  • Neurological Research Institute /ID# 242688

    Santa Monica, California 90404
    United States

    Site Not Available

  • Neurology Offices of South Florida, PLLC /ID# 242693

    Boca Raton, Florida 33428-2231
    United States

    Site Not Available

  • Coastal Clinical Research Specialists /ID# 247993

    Fernandina Beach, Florida 32034-4779
    United States

    Site Not Available

  • Northwest Florida Clinical Research Group, LLC /ID# 242691

    Gulf Breeze, Florida 32561-4495
    United States

    Site Not Available

  • Coastal Clinical Research Specialists /ID# 247992

    Jacksonville Beach, Florida 32250-1694
    United States

    Site Not Available

  • University of Miami /ID# 252230

    Miami, Florida 33136
    United States

    Site Not Available

  • First Physicians Group - Waldemere /ID# 242861

    Sarasota, Florida 34239-2943
    United States

    Site Not Available

  • Robbins Headache Clinic /ID# 243618

    Riverwoods, Illinois 60015-5711
    United States

    Site Not Available

  • Kansas Institute of Research /ID# 241796

    Overland Park, Kansas 66211-1363
    United States

    Site Not Available

  • Ochsner Clinic Foundation /ID# 241803

    Covington, Louisiana 70433-8107
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center /ID# 241800

    Boston, Massachusetts 02215-5400
    United States

    Site Not Available

  • MedVadis Research /ID# 242948

    Waltham, Massachusetts 02451-1105
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute (MHNI) /ID# 241784

    Ann Arbor, Michigan 48104-5131
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology - Burnsville /ID# 241994

    Burnsville, Minnesota 55337-6732
    United States

    Site Not Available

  • The Headache Center /ID# 242537

    Ridgeland, Mississippi 39157-2073
    United States

    Site Not Available

  • Albany Medical College /ID# 242757

    Albany, New York 12208
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc. /ID# 241776

    Amherst, New York 14226
    United States

    Site Not Available

  • Headache Wellness Center /ID# 241791

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • University of Cincinnati /ID# 243599

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Jefferson Hospital for Neuroscience /ID# 243712

    Philadelphia, Pennsylvania 19107-5191
    United States

    Site Not Available

  • Frontier Clinical Research /ID# 242927

    Smithfield, Pennsylvania 15478
    United States

    Site Not Available

  • Preferred Primary Care Physicians - Jacob Murphy /ID# 241798

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Chattanooga Medical Research /ID# 253295

    Chattanooga, Tennessee 37404-3239
    United States

    Site Not Available

  • Nashville Neuroscience Group /ID# 243592

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Neurology /ID# 241795

    Dallas, Texas 75214
    United States

    Site Not Available

  • Inova Health System /ID# 252242

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Integrated Neurology Services - Falls Church /ID# 244747

    Falls Church, Virginia 22043-2367
    United States

    Site Not Available

  • Puget Sound Neurology /ID# 241787

    Tacoma, Washington 25328
    United States

    Site Not Available

  • Frontier Clinical Research - Kingwood /ID# 242928

    Kingwood, West Virginia 26537-9797
    United States

    Site Not Available

  • West Virginia Univ School Med /ID# 252869

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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