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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine
• Intervention / Treatment: Drug: Atogepant

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Alabama
    • Hoover, Alabama, United States, 35244-5700
      • Recruiting
      • Neurology and Neurodiagnostics of Alabama /ID# 242538
  • Arizona
    • Phoenix, Arizona, United States, 85013-4407
      • Recruiting
      • Barrow Neurological Institute /ID# 241812
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Completed
      • Arkansas Clinical Research /ID# 241789
  • California
    • Canoga Park, California, United States, 91303-1855
      • Recruiting
      • Hope Clinical Research /ID# 241772
    • Carlsbad, California, United States, 92011-4213
      • Recruiting
      • Profound Research LLC /ID# 244084
    • Fresno, California, United States, 93710-5473
      • Recruiting
      • Neuro Pain Medical Center /ID# 241992
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Neurological Research Institute /ID# 242688
  • Florida
    • Boca Raton, Florida, United States, 33428-2231
      • Recruiting
      • Neurology Offices of South Florida, PLLC /ID# 242693
    • Jacksonville Beach, Florida, United States, 32250-1694
      • Recruiting
      • Coastal Clinical Research Specialists /ID# 247992
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami /ID# 252230
    • Sarasota, Florida, United States, 34239-2943
      • Recruiting
      • First Physicians Group - Waldemere /ID# 242861
  • Kansas
    • Overland Park, Kansas, United States, 66211-1363
      • Recruiting
      • Kansas Institute of Research /ID# 241796
  • Louisiana
    • Covington, Louisiana, United States, 70433-8107
      • Recruiting
      • Ochsner Clinic Foundation /ID# 241803
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Recruiting
      • Beth Israel Deaconess Medical Center /ID# 241800
  • Michigan
    • Ann Arbor, Michigan, United States, 48104-5131
      • Recruiting
      • Michigan Headache & Neurological Institute (MHNI) /ID# 241784
  • Minnesota
    • Burnsville, Minnesota, United States, 55337-6732
      • Recruiting
      • Minneapolis Clinic of Neurology - Burnsville /ID# 241994
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical College /ID# 242757
      • Contact: Site Coordinator; Phone Number: 650-815-9807
    • Amherst, New York, United States, 14226
      • Recruiting
      • Dent Neurosciences Research Center, Inc. /ID# 241776
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Headache Wellness Center /ID# 241791
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-5191
      • Recruiting
      • Jefferson Hospital for Neuroscience /ID# 243712
    • Uniontown, Pennsylvania, United States, 15401
      • Recruiting
      • Preferred Primary Care Physicians - Jacob Murphy /ID# 241798
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404-3239
      • Recruiting
      • Chattanooga Medical Research /ID# 253295
      • Contact: Site Coordinator; Phone Number: 423-648-7794
    • Nashville, Tennessee, United States, 37203-2646
      • Recruiting
      • Nashville Neuroscience Group /ID# 243592
  • Texas
    • Dallas, Texas, United States, 75214
      • Recruiting
      • Texas Neurology /ID# 241795
  • Virginia
    • Falls Church, Virginia, United States, 22043-2367
      • Recruiting
      • Integrated Neurology Services - Falls Church /ID# 244747
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Health System /ID# 252242
  • Washington
    • Tacoma, Washington, United States, 25328
      • Recruiting
      • Puget Sound Neurology /ID# 241787
  • West Virginia
    • Kingwood, West Virginia, United States, 26537-9797
      • Recruiting
      • Frontier Clinical Research - Kingwood /ID# 242928
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia Univ School Med /ID# 252869

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atogepant; Participants will receive atogepant once a day (QD) during the 24-week treatment period.	Drug: Atogepant; Oral Tablet; Other Names: QULIPTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 28 Weeks
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.	Baseline (Week 0) through 24 Weeks
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.	Baseline (Week 0) through 24 Weeks
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.	Baseline (Week 0) through 24 Weeks
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.	Baseline (Week 0) through 24 Weeks
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.	Baseline (Week 0) through 24 Weeks
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.	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	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.	Baseline (Week 0) through 24 Weeks
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	Baseline (Week 0) through 24 Weeks
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).	Baseline (Week 0) through 24 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Monthly Migraine Days	Change from Baseline in monthly migraine days, defined by IHS Guidelines 2018 will be assessed.	Baseline (Week 0) through 24 Weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): December 27, 2024
• Study Completion (Estimated): December 27, 2024

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; OnabotulinumtoxinA; Chronic Migraine; BOTOX; Atogepant; QULIPTA
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: M22-418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No