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

Completed · Phase 3

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID

NCT05216263

Run by

AbbVie

People needed

75

Starts

2022-03-22

Expected to finish

2025-05-02

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least a 1-year history of chronic migraine (CM), with or without aura, consistent with a diagnosis according to International Classification of Headache Disorders 3rd edition (ICHD-3 2018) and with or without acute medication overuse as defined in the protocol.
• 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).

You may not qualify if…

• Use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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