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

ClinicalTrials.gov processed this data on June 10, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

RECRUITING (See Contacts and Locations)
Verified June 2024 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT05216263
Other Study ID Numbers: M22-418
First Submitted: January 19, 2022
First Posted: January 31, 2022
Last Update Posted: June 12, 2024
Last Verified: June 2024
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Chronic Migraine
  • Drug: Atogepant

Study Design

Study TypeInterventional
Anticipated 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 22, 2022
Anticipated Primary Completion DateDecember 27, 2024
Anticipated Study Completion DateApril 4, 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) [Up to approximately 28 Weeks]
    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) [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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 [Baseline (Week 0) through 24 Weeks]
    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) [Baseline (Week 0) through 24 Weeks]
    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 18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
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 Collaborators AbbVie
Locations
  • Neurology and Neurodiagnostics of Alabama /ID# 242538 | Hoover, Alabama, United States, 35244-5700
  • Barrow Neurological Institute /ID# 241812 | Phoenix, Arizona, United States, 85013
  • Arkansas Clinical Research /ID# 241789 | Little Rock, Arkansas, United States, 72205
  • Hope Clinical Research /ID# 241772 | Canoga Park, California, United States, 91303
  • Profound Research LLC /ID# 244084 | Carlsbad, California, United States, 92011-4213
  • Neuro Pain Medical Center /ID# 241992 | Fresno, California, United States, 93710-5473
  • Neurological Research Institute /ID# 242688 | Santa Monica, California, United States, 90404
  • Neurology Offices of South Florida, PLLC /ID# 242693 | Boca Raton, Florida, United States, 33428-2231
  • Coastal Clinical Research Specialists /ID# 247992 | Jacksonville Beach, Florida, United States, 32250-1694
  • University of Miami /ID# 252230 | Miami, Florida, United States, 33136
  • First Physicians Group - Waldemere /ID# 242861 | Sarasota, Florida, United States, 34239-2943
  • Kansas Institute of Research /ID# 241796 | Overland Park, Kansas, United States, 66211-1363
  • Ochsner Clinic Foundation /ID# 241803 | Covington, Louisiana, United States, 70433-8107
  • Beth Israel Deaconess Medical Center /ID# 241800 | Boston, Massachusetts, United States, 02215-5400
  • Michigan Headache & Neurological Institute (MHNI) /ID# 241784 | Ann Arbor, Michigan, United States, 48104-5131
  • Minneapolis Clinic of Neurology - Burnsville /ID# 241994 | Burnsville, Minnesota, United States, 55337-6732
  • Albany Medical College /ID# 242757 | Albany, New York, United States, 12208
  • Dent Neurosciences Research Center, Inc. /ID# 241776 | Amherst, New York, United States, 14226
  • Headache Wellness Center /ID# 241791 | Greensboro, North Carolina, United States, 27405
  • Jefferson Hospital for Neuroscience /ID# 243712 | Philadelphia, Pennsylvania, United States, 19107-5191
  • Preferred Primary Care Physicians - Jacob Murphy /ID# 241798 | Uniontown, Pennsylvania, United States, 15401
  • Chattanooga Medical Research /ID# 253295 | Chattanooga, Tennessee, United States, 37404-3239
  • Nashville Neuroscience Group /ID# 243592 | Nashville, Tennessee, United States, 37203
  • Texas Neurology /ID# 241795 | Dallas, Texas, United States, 75214
  • Inova Health System /ID# 252242 | Falls Church, Virginia, United States, 22042
  • Integrated Neurology Services - Falls Church /ID# 244747 | Falls Church, Virginia, United States, 22043-2367
  • Puget Sound Neurology /ID# 241787 | Tacoma, Washington, United States, 25328
  • Frontier Clinical Research - Kingwood /ID# 242928 | Kingwood, West Virginia, United States, 26537-9797
  • West Virginia Univ School Med /ID# 252869 | Morgantown, West Virginia, United States, 26506
Investigators

    More Information

    Additional Information

    Additional Relevant MeSH Terms

    • Migraine Disorders
    • Headache Disorders, Primary
    • Headache Disorders
    • Brain Diseases
    • Central Nervous System Diseases
    • Nervous System Diseases