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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Experimental | Participants received atogepant 60 mg once a day (QD) during the 24-week treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
|
|
| 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 drug. 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From first dose of study drug until 4 weeks following last dose of study drug (up to 28 weeks) |
| Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. Glomerular Filtration Rate (GFR) is a clinical measurement that calculates how many milliliters of blood the kidneys filter every second. Glucose, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of sugar. Protein, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of protein. | From first dose of study drug until last dose of study drug (24 weeks) |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting], pulse rate [sitting], and weight. Number of participants with non-PCS baseline values who met the PCS criterion at least once post-baseline are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology and Neurodiagnostics of Alabama /ID# 242538 | Hoover | Alabama | 35244-5700 | United States | ||
| Barrow Neurological Institute - Dignity Health St. Joseph's Hosp and Medical Ctr /ID# 241812 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41944477 | Derived | Rothrock J, Najib U, Ailani J, Ashina S, Bao J, Smith JH, Adams AM, Dabruzzo B, Pfleeger K, Blumenfeld A. Safety, tolerability, and efficacy of atogepant added to onabotulinumtoxinA for the preventive treatment of chronic migraine: A phase 3, multicenter, 24-week, open-label study. Cephalalgia. 2026 Apr;46(4):3331024261429118. doi: 10.1177/03331024261429118. Epub 2026 Apr 7. |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
The Safety population included all participants with at least 1 dose of atogepant study drug (N=75).
The screening/baseline period was up to 12 weeks, which included at least 28 days of eDiary collection of migraine days and headache days at the end of the screening/baseline period.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2024 | Mar 9, 2026 |
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| From first dose of study drug until last dose of study drug (24 weeks) |
| Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). | From first dose of study drug until last dose of study drug (24 weeks) |
| Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | 12-lead ECGs were performed at select study visits. | From first dose of study drug until last dose of study drug (24 weeks) |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Arkansas Clinical Research /ID# 241789 | Little Rock | Arkansas | 72205 | United States |
| Hope Clinical Research /ID# 241772 | Canoga Park | California | 91303 | United States |
| Profound Research LLC /ID# 244084 | Carlsbad | California | 92011-4213 | United States |
| Neuro Pain Medical Center /ID# 241992 | Fresno | California | 93710 | United States |
| Neurological Research Institute /ID# 242688 | Santa Monica | California | 90404 | United States |
| Neurology Offices of South Florida, PLLC /ID# 242693 | Boca Raton | Florida | 33428-2231 | United States |
| Coastal Clinical Research Specialists /ID# 247992 | Jacksonville Beach | Florida | 32250-1694 | United States |
| University of Miami /ID# 252230 | Miami | Florida | 33136 | United States |
| First Physicians Group - Waldemere /ID# 242861 | Sarasota | Florida | 34239-2943 | United States |
| Kansas Institute of Research /ID# 241796 | Overland Park | Kansas | 66211-1363 | United States |
| Duplicate_Ochsner Clinic Foundation /ID# 241803 | Covington | Louisiana | 70433-8107 | United States |
| Beth Israel Deaconess Medical Center /ID# 241800 | Boston | Massachusetts | 02215-5400 | United States |
| Michigan Headache & Neurological Institute (MHNI) /ID# 241784 | Ann Arbor | Michigan | 48104-5131 | United States |
| Minneapolis Clinic of Neurology - Burnsville /ID# 241994 | Burnsville | Minnesota | 55337-6732 | United States |
| Albany Medical College /ID# 242757 | Albany | New York | 12208 | United States |
| Dent Neurologic Institute - Amherst /ID# 241776 | Amherst | New York | 14226 | United States |
| Headache Wellness Center /ID# 241791 | Greensboro | North Carolina | 27405 | United States |
| Jefferson Hospital for Neuroscience /ID# 243712 | Philadelphia | Pennsylvania | 19107-5191 | United States |
| Preferred Primary Care Physicians - Jacob Murphy /ID# 241798 | Uniontown | Pennsylvania | 15401 | United States |
| Chattanooga Medical Research /ID# 253295 | Chattanooga | Tennessee | 37404-3239 | United States |
| Nashville Neuroscience Group /ID# 243592 | Nashville | Tennessee | 37203 | United States |
| Texas Neurology /ID# 241795 | Dallas | Texas | 75214 | United States |
| Inova Health System /ID# 252242 | Falls Church | Virginia | 22042 | United States |
| Integrated Neurology Services - Falls Church /ID# 244747 | Falls Church | Virginia | 22043-2367 | United States |
| Puget Sound Neurology /ID# 241787 | Tacoma | Washington | 25328 | United States |
| Frontier Clinical Research - Kingwood /ID# 242928 | Kingwood | West Virginia | 26537-9797 | United States |
| West Virginia Univ School Med /ID# 252869 | Morgantown | West Virginia | 26506 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 drug. 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Safety Population. | Posted | Count of Participants | Participants | From first dose of study drug until 4 weeks following last dose of study drug (up to 28 weeks) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator | Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis. Glomerular Filtration Rate (GFR) is a clinical measurement that calculates how many milliliters of blood the kidneys filter every second. Glucose, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of sugar. Protein, Urinalysis: At least 1+ indicates that the urine contains an increased concentration of protein. | Safety population: Number analyzed are participants with data available for analyses of the specific category. | Posted | Number | number of participants | From first dose of study drug until last dose of study drug (24 weeks) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting], pulse rate [sitting], and weight. Number of participants with non-PCS baseline values who met the PCS criterion at least once post-baseline are reported. | Safety Population. The number of participants with non-PCS baseline value and at least one post-baseline assessment are included in the analysis. | Posted | Number | number of participants | From first dose of study drug until last dose of study drug (24 weeks) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior). | Safety Population. Two participants were not assessed and were not included in this analysis. Participants are only counted once for each suicidal ideation and each suicidal behavior. Only the most severe suicidal ideation and the most severe suicidal behavior across all visits during the specific period are counted for each participant. | Posted | Number | number of participants | From first dose of study drug until last dose of study drug (24 weeks) |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator | 12-lead ECGs were performed at select study visits. | Safety Population. Participants with non-PCS baseline value and at least one post-baseline assessment are included. | Posted | Number | number of participants | From first dose of study drug until last dose of study drug (24 weeks) |
|
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All-cause mortality and adverse event tables include events reported from enrollment to the end of the study. The median time on follow-up was 225 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants received concomitant atogepant 60 mg QD from Day 1 to Week 24, along with their stable BOTOX (155 to 200 units, targeting approximately 50% of participants receiving 155 units). BOTOX was administered on Visits 2, 5, and 8. Final visit of treatment period was Week 24. Post-atogepant treatment follow-up occurred at Week 28 (or 4 weeks post-atogepant treatment for premature discontinuation). | 0 | 75 | 2 | 75 | 29 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2025 | Mar 9, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Any severe TEAE |
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| Any Treatment-emergent Serious Adverse Event (TESAE) |
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| AE leading to withdrawal of atogepant study treatment |
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| AE leading to withdrawal of BOTOX treatment |
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| Any TEAE leading to death |
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| Counts |
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| Participants |
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