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NCT05216263CompletedPhase 3

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

A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
75 (actual)
First submitted
19 Jan 2022
Start date
22 Mar 2022
Primary completion date
2 May 2025
Lead sponsor
AbbVie
Diseases
Migraine
NCT number
NCT05216263

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 75
  • From 22 Mar 2022 to the primary completion date, 2 May 2025
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Albany Medical College /ID# 242757
Coordinator of this site? Confirm its status		AlbanyUnited StatesUnknown status
Dent Neurologic Institute - Amherst /ID# 241776
Coordinator of this site? Confirm its status		AmherstUnited StatesUnknown status
Michigan Headache & Neurological Institute (MHNI) /ID# 241784
Coordinator of this site? Confirm its status		Ann ArborUnited StatesUnknown status
Neurology Offices of South Florida, PLLC /ID# 242693
Coordinator of this site? Confirm its status		Boca RatonUnited StatesUnknown status
Beth Israel Deaconess Medical Center /ID# 241800
Coordinator of this site? Confirm its status		BostonUnited StatesUnknown status
Minneapolis Clinic of Neurology - Burnsville /ID# 241994
Coordinator of this site? Confirm its status		BurnsvilleUnited StatesUnknown status
Hope Clinical Research /ID# 241772
Coordinator of this site? Confirm its status		Canoga ParkUnited StatesUnknown status
Profound Research LLC /ID# 244084
Coordinator of this site? Confirm its status		CarlsbadUnited StatesUnknown status
Chattanooga Medical Research /ID# 253295
Coordinator of this site? Confirm its status		ChattanoogaUnited StatesUnknown status
Duplicate_Ochsner Clinic Foundation /ID# 241803
Coordinator of this site? Confirm its status		CovingtonUnited StatesUnknown status
Texas Neurology /ID# 241795
Coordinator of this site? Confirm its status		DallasUnited StatesUnknown status
Integrated Neurology Services - Falls Church /ID# 244747
Coordinator of this site? Confirm its status		Falls ChurchUnited StatesUnknown status
Inova Health System /ID# 252242
Coordinator of this site? Confirm its status		Falls ChurchUnited StatesUnknown status
Neuro Pain Medical Center /ID# 241992
Coordinator of this site? Confirm its status		FresnoUnited StatesUnknown status
Headache Wellness Center /ID# 241791
Coordinator of this site? Confirm its status		GreensboroUnited StatesUnknown status
Neurology and Neurodiagnostics of Alabama /ID# 242538
Coordinator of this site? Confirm its status		HooverUnited StatesUnknown status
Coastal Clinical Research Specialists /ID# 247992
Coordinator of this site? Confirm its status		Jacksonville BeachUnited StatesUnknown status
Frontier Clinical Research - Kingwood /ID# 242928
Coordinator of this site? Confirm its status		KingwoodUnited StatesUnknown status
Arkansas Clinical Research /ID# 241789
Coordinator of this site? Confirm its status		Little RockUnited StatesUnknown status
University of Miami /ID# 252230
Coordinator of this site? Confirm its status		MiamiUnited StatesUnknown status
West Virginia Univ School Med /ID# 252869
Coordinator of this site? Confirm its status		MorgantownUnited StatesUnknown status
Nashville Neuroscience Group /ID# 243592
Coordinator of this site? Confirm its status		NashvilleUnited StatesUnknown status
Kansas Institute of Research /ID# 241796
Coordinator of this site? Confirm its status		Overland ParkUnited StatesUnknown status
Jefferson Hospital for Neuroscience /ID# 243712
Coordinator of this site? Confirm its status		PhiladelphiaUnited StatesUnknown status
Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812
Coordinator of this site? Confirm its status		PhoenixUnited StatesUnknown status
Neurological Research Institute /ID# 242688
Coordinator of this site? Confirm its status		Santa MonicaUnited StatesUnknown status
First Physicians Group - Waldemere /ID# 242861
Coordinator of this site? Confirm its status		SarasotaUnited StatesUnknown status
Puget Sound Neurology /ID# 241787
Coordinator of this site? Confirm its status		TacomaUnited StatesUnknown status
Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
Coordinator of this site? Confirm its status		UniontownUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.