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

NCT05216263 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: M22-418
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; Migraine; Atogepant; OnabotulinumtoxinA; BOTOX; QULIPTA

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Atogepant

EXPERIMENTAL

Participants will receive atogepant once a day (QD) during the 24-week treatment period.

Drug: Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: QULIPTA

Atogepant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (29)

Neurology and Neurodiagnostics of Alabama /ID# 242538

Hoover, Alabama, 35244-5700, United States

Location

Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812

Phoenix, Arizona, 85013, United States

Location

Arkansas Clinical Research /ID# 241789

Little Rock, Arkansas, 72205, United States

Location

Hope Clinical Research /ID# 241772

Canoga Park, California, 91303, United States

Location

Profound Research LLC /ID# 244084

Carlsbad, California, 92011-4213, United States

Location

Neuro Pain Medical Center /ID# 241992

Fresno, California, 93710-5473, United States

Location

Neurological Research Institute /ID# 242688

Santa Monica, California, 90404, United States

Location

Neurology Offices of South Florida, PLLC /ID# 242693

Boca Raton, Florida, 33428-2231, United States

Location

Coastal Clinical Research Specialists /ID# 247992

Jacksonville Beach, Florida, 32250-1694, United States

Location

University of Miami /ID# 252230

Miami, Florida, 33136, United States

Location

First Physicians Group - Waldemere /ID# 242861

Sarasota, Florida, 34239-2943, United States

Location

Kansas Institute of Research /ID# 241796

Overland Park, Kansas, 66211-1363, United States

Location

Ochsner Clinic Foundation /ID# 241803

Covington, Louisiana, 70433-8107, United States

Location

Beth Israel Deaconess Medical Center /ID# 241800

Boston, Massachusetts, 02215-5400, United States

Location

Michigan Headache & Neurological Institute (MHNI) /ID# 241784

Ann Arbor, Michigan, 48104-5131, United States

Location

Minneapolis Clinic of Neurology - Burnsville /ID# 241994

Burnsville, Minnesota, 55337-6732, United States

Location

Albany Medical College /ID# 242757

Albany, New York, 12208, United States

Location

Dent Neurologic Institute - Amherst /ID# 241776

Amherst, New York, 14226, United States

Location

Headache Wellness Center /ID# 241791

Greensboro, North Carolina, 27405, United States

Location

Jefferson Hospital for Neuroscience /ID# 243712

Philadelphia, Pennsylvania, 19107-5191, United States

Location

Preferred Primary Care Physicians - Jacob Murphy /ID# 241798

Uniontown, Pennsylvania, 15401, United States

Location

Chattanooga Medical Research /ID# 253295

Chattanooga, Tennessee, 37404-3239, United States

Location

Nashville Neuroscience Group /ID# 243592

Nashville, Tennessee, 37203, United States

Location

Texas Neurology /ID# 241795

Dallas, Texas, 75214, United States

Location

Inova Health System /ID# 252242

Falls Church, Virginia, 22042, United States

Location

Integrated Neurology Services - Falls Church /ID# 244747

Falls Church, Virginia, 22043-2367, United States

Location

Puget Sound Neurology /ID# 241787

Tacoma, Washington, 25328, United States

Location

Frontier Clinical Research - Kingwood /ID# 242928

Kingwood, West Virginia, 26537-9797, United States

Location

West Virginia Univ School Med /ID# 252869

Morgantown, West Virginia, 26506, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: March 22, 2022
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (29)