EichorEICHOR
Study identifier: NCT05216263 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedATO-BOTOX

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

Condition: Chronic Migraine  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants75
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where29 locations

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (29)

Neurology and Neurodiagnostics of Alabama /ID# 242538Hoover, Alabama, United States
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812Phoenix, Arizona, United States
Arkansas Clinical Research /ID# 241789Little Rock, Arkansas, United States
Hope Clinical Research /ID# 241772Canoga Park, California, United States
Profound Research LLC /ID# 244084Carlsbad, California, United States
Neuro Pain Medical Center /ID# 241992Fresno, California, United States
Neurological Research Institute /ID# 242688Santa Monica, California, United States
Neurology Offices of South Florida, PLLC /ID# 242693Boca Raton, Florida, United States
Coastal Clinical Research Specialists /ID# 247992Jacksonville Beach, Florida, United States
University of Miami /ID# 252230Miami, Florida, United States
First Physicians Group - Waldemere /ID# 242861Sarasota, Florida, United States
Kansas Institute of Research /ID# 241796Overland Park, Kansas, United States

+ 17 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

HooverPhoenixLittle RockCanoga Park

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.

Look up another condition
Look up another city
Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →