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

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 October 31, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified October 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: November 1, 2024
Last Verified: October 2024
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Chronic Migraine	Drug: Atogepant

Study Design

Study Type	Interventional
Actual Enrollment	75 participants
Design Allocation	N/A
Interventional Model	Single Group Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	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
Study Start Date	March 22, 2022
Anticipated Primary Completion Date	April 4, 2025
Anticipated Study Completion Date	April 4, 2025

Groups and Cohorts

Group/ Cohort	Intervention/ 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

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.
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.
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.
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.
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.
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.
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.
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.
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
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 - Dignity Health St. Joseph's Hosp and Medical Ctr /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

Related Info

Additional Relevant MeSH Terms

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