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New combo therapy for chronic migraine: atogepant plus botox under study

NCT ID NCT05216263

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether adding the oral drug atogepant (QULIPTA) to standard Botox injections can safely and effectively prevent chronic migraine in adults. 75 participants took atogepant daily for 24 weeks alongside their regular Botox. Researchers monitored side effects, lab values, and migraine changes. The study is complete, but results are not yet published.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atogepant (QULIPTA) oral tablet
What this could lead to
If successful, this could show that adding atogepant to Botox provides better migraine prevention than Botox alone, offering a new combination treatment option.
What could go wrong
This is an open-label study with no placebo group, so results may be less reliable. Side effects like nausea, constipation, or suicidal thoughts are possible. The small size (75 people) limits generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

75 people

The number who actually took part.

Started

Mar 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic migraine

Contacts and locations

Locations

  • Albany Medical College /ID# 242757

    Albany, New York, 12208, United States

  • Arkansas Clinical Research /ID# 241789

    Little Rock, Arkansas, 72205, United States

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

    Phoenix, Arizona, 85013, United States

  • Beth Israel Deaconess Medical Center /ID# 241800

    Boston, Massachusetts, 02215-5400, United States

  • Chattanooga Medical Research /ID# 253295

    Chattanooga, Tennessee, 37404-3239, United States

  • Coastal Clinical Research Specialists /ID# 247992

    Jacksonville Beach, Florida, 32250-1694, United States

  • Dent Neurologic Institute - Amherst /ID# 241776

    Amherst, New York, 14226, United States

  • Duplicate_Ochsner Clinic Foundation /ID# 241803

    Covington, Louisiana, 70433-8107, United States

  • First Physicians Group - Waldemere /ID# 242861

    Sarasota, Florida, 34239-2943, United States

  • Frontier Clinical Research - Kingwood /ID# 242928

    Kingwood, West Virginia, 26537-9797, United States

  • Headache Wellness Center /ID# 241791

    Greensboro, North Carolina, 27405, United States

  • Hope Clinical Research /ID# 241772

    Canoga Park, California, 91303, United States

  • Inova Health System /ID# 252242

    Falls Church, Virginia, 22042, United States

  • Integrated Neurology Services - Falls Church /ID# 244747

    Falls Church, Virginia, 22043-2367, United States

  • Jefferson Hospital for Neuroscience /ID# 243712

    Philadelphia, Pennsylvania, 19107-5191, United States

  • Kansas Institute of Research /ID# 241796

    Overland Park, Kansas, 66211-1363, United States

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

    Ann Arbor, Michigan, 48104-5131, United States

  • Minneapolis Clinic of Neurology - Burnsville /ID# 241994

    Burnsville, Minnesota, 55337-6732, United States

  • Nashville Neuroscience Group /ID# 243592

    Nashville, Tennessee, 37203, United States

  • Neuro Pain Medical Center /ID# 241992

    Fresno, California, 93710, United States

  • Neurological Research Institute /ID# 242688

    Santa Monica, California, 90404, United States

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

    Boca Raton, Florida, 33428-2231, United States

  • Neurology and Neurodiagnostics of Alabama /ID# 242538

    Hoover, Alabama, 35244-5700, United States

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

    Uniontown, Pennsylvania, 15401, United States

  • Profound Research LLC /ID# 244084

    Carlsbad, California, 92011-4213, United States

  • Puget Sound Neurology /ID# 241787

    Tacoma, Washington, 25328, United States

  • Texas Neurology /ID# 241795

    Dallas, Texas, 75214, United States

  • University of Miami /ID# 252230

    Miami, Florida, 33136, United States

  • West Virginia Univ School Med /ID# 252869

    Morgantown, West Virginia, 26506, United States

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