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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified April 2025 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT05216263
Other Study ID Numbers:
M22-418
First Submitted
January 18, 2022
First Posted
January 30, 2022
Last Update Posted
May 15, 2025
Last Verified
April 2025

ClinicalTrials.gov processed this data on May 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Chronic Migraine
Drug: Atogepant

Study Design

Study TypeInterventional
Actual Enrollment75 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 21, 2022
Actual Primary Completion DateMay 1, 2025
Actual Study Completion DateMay 1, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Atogepant
Participants will receive atogepant once a day (QD) during the 24-week treatment period.
Drug: Atogepant
Oral Tablet

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Adverse Events (AEs)
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
  2. Responder Status of at least 25% Reduction in the Frequency of Monthly Migraine Days Collected via Daily Electronic Diary (eDiary)
    Percentage of participants achieving at least 25% reduction from baseline in the frequency of monthly migraine days will be assessed.
  3. Responder Status of at least 30% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
    Percentage of participants achieving at least 30% reduction from baseline in the frequency of monthly migraine days will be assessed.
  4. Responder Status of at least 50% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
    Percentage of participants achieving at least 50% reduction from baseline in the frequency of monthly migraine days will be assessed.
  5. Responder Status of at least 75% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
    Percentage of participants achieving at least 75% reduction from baseline in the frequency of monthly migraine days will be assessed.
  6. Responder Status of at least 100% Reduction in the Frequency of Monthly Migraine Days Collected via eDiary
    Percentage of participants achieving at least 100% reduction from baseline in the frequency of monthly migraine days will be assessed.
  7. Change From Baseline in Monthly Migraine Days
    Change from Baseline in monthly migraine days, defined by International Headache Society (IHS) Guidelines 2018 will be assessed.
  8. Change from Baseline in Monthly Headache Days, Moderate or Severe Headache Days, Cumulative Hours of Headache, Acute Treatment Medication Use Days, Headache Free Days, and Migraine Symptom-Free Days
    Change from baseline in monthly headache days, moderate or severe headache days, cumulative hours of headache, acute treatment medication use days, headache free days, and migraine symptom-free days, defined by IHS Guidelines 2018 will be assessed.
  9. Change from Baseline in Monthly days with Non-Headache Migraine Symptoms
    Change from baseline in monthly days with non-headache migraine symptoms such as photophobia, phonophobia, nausea and/or vomiting, dizziness, neck pain, tiredness, mood change, yawning, thirst, cravings, urinary frequency, cranial autonomic symptoms
  10. Change from Baseline in Monthly Activity Impairment in Migraine - Diary (AIM-D)
    The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Neurology and Neurodiagnostics of Alabama /ID# 242538 | Hoover Alabama, United States, 35244-5700Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812 | Phoenix Arizona, United States, 85013Arkansas Clinical Research /ID# 241789 | Little Rock Arkansas, United States, 72205Hope Clinical Research /ID# 241772 | Canoga Park California, United States, 91303Profound Research LLC /ID# 244084 | Carlsbad California, United States, 92011-4213Neuro Pain Medical Center /ID# 241992 | Fresno California, United States, 93710-5473Neurological Research Institute /ID# 242688 | Santa Monica California, United States, 90404Neurology Offices of South Florida, PLLC /ID# 242693 | Boca Raton Florida, United States, 33428-2231Coastal Clinical Research Specialists /ID# 247992 | Jacksonville Beach Florida, United States, 32250-1694University of Miami /ID# 252230 | Miami Florida, United States, 33136First Physicians Group - Waldemere /ID# 242861 | Sarasota Florida, United States, 34239-2943Kansas Institute of Research /ID# 241796 | Overland Park Kansas, United States, 66211-1363Ochsner Clinic Foundation /ID# 241803 | Covington Louisiana, United States, 70433-8107Beth Israel Deaconess Medical Center /ID# 241800 | Boston Massachusetts, United States, 02215-5400Michigan Headache & Neurological Institute (MHNI) /ID# 241784 | Ann Arbor Michigan, United States, 48104-5131Minneapolis Clinic of Neurology - Burnsville /ID# 241994 | Burnsville Minnesota, United States, 55337-6732Albany Medical College /ID# 242757 | Albany New York, United States, 12208Dent Neurologic Institute - Amherst /ID# 241776 | Amherst New York, United States, 14226Headache Wellness Center /ID# 241791 | Greensboro North Carolina, United States, 27405Jefferson Hospital for Neuroscience /ID# 243712 | Philadelphia Pennsylvania, United States, 19107-5191Preferred Primary Care Physicians - Jacob Murphy /ID# 241798 | Uniontown Pennsylvania, United States, 15401Chattanooga Medical Research /ID# 253295 | Chattanooga Tennessee, United States, 37404-3239Nashville Neuroscience Group /ID# 243592 | Nashville Tennessee, United States, 37203Texas Neurology /ID# 241795 | Dallas Texas, United States, 75214Inova Health System /ID# 252242 | Falls Church Virginia, United States, 22042Integrated Neurology Services - Falls Church /ID# 244747 | Falls Church Virginia, United States, 22043-2367Puget Sound Neurology /ID# 241787 | Tacoma Washington, United States, 25328Frontier Clinical Research - Kingwood /ID# 242928 | Kingwood West Virginia, United States, 26537-9797West Virginia Univ School Med /ID# 252869 | Morgantown West Virginia, United States, 26506
Investigators
Study Director: ABBVIE INC., AbbVie