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The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant 60 mg | Experimental | Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Atogepant Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | 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 dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values 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. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Trugman, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research US, Inc. | Chandler | Arizona | 85224 | United States | ||
| Alea Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39648629 | Derived | Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753. | |
| 38462625 | Derived | Rizzoli P, Marmura MJ, Robblee J, McVige J, Sacco S, Nahas SJ, Ailani J, De Abreu Ferreira R, Ma J, Smith JH, Dabruzzo B, Ashina M. Safety and tolerability of atogepant for the preventive treatment of migraine: a post hoc analysis of pooled data from four clinical trials. J Headache Pain. 2024 Mar 11;25(1):35. doi: 10.1186/s10194-024-01736-z. |
| Label | URL |
|---|---|
| Related Info | View source |
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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 and 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.
For details on when studies are available for sharing, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants rolled over from the lead-in study 3101-301-002 (NCT03777059) into this extension study. This study consisted of two periods: Open-label (OL) Treatment Period and Safety Follow-up Period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| OL Treatment Period (40 Weeks) |
|
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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 | Sep 15, 2020 | Mar 15, 2022 |
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| Up to Week 44 |
| 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. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. | Up to Week 40 |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. | Up to Week 44 |
| Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior. | OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44 |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Central Phoenix Medical Clinic | Phoenix | Arizona | 85020 | United States |
| Orange Grove Family Practice | Tucson | Arizona | 85741 | United States |
| Principals Research Group | Hot Springs | Arkansas | 71901 | United States |
| Arkansas Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | United States |
| Med Center Medical Clinic | Carmichael | California | 95608 | United States |
| Neuro Pain Medical Center | Fresno | California | 93710 | United States |
| California Headache and Balance Center | Fresno | California | 93720 | United States |
| Grossmont Center for Clinical Research | La Mesa | California | 91942 | United States |
| Paradigm Clinical Research Centers, Inc | La Mesa | California | 91942 | United States |
| Torrance Clinical Research Institute, Inc. | Lomita | California | 90731 | United States |
| Long Beach Clinical Trials Services | Long Beach | California | 90806 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Newport Beach Clinical Research Associates | Newport Beach | California | 92663 | United States |
| Excell Research, Inc. | Oceanside | California | 92056 | United States |
| Rancho Cucamonga Clinical Trials | Rancho Cucamonga | California | 91730 | United States |
| Desert Valley Research | Redlands | California | 92374 | United States |
| George J. Rederich, M.D. Inc. | Redondo Beach | California | 90277 | United States |
| Optimus Medical Group | San Francisco | California | 94102 | United States |
| California Neuroscience Research | Sherman Oaks | California | 91403 | United States |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | United States |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Aventura Neurological Associates | Aventura | Florida | 33180 | United States |
| Neurology Offices of South Florida | Boca Raton | Florida | 33428 | United States |
| Sarkis Clinical Trials- Gainesville | Gainesville | Florida | 32607 | United States |
| Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Well Pharma Medical Research, Corp | Miami | Florida | 33173 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | United States |
| Sarasota Memorial Hospital Clinical Research Center | Sarasota | Florida | 34239 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Neurotrials Research | Atlanta | Georgia | 30328 | United States |
| Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology | Atlanta | Georgia | 30328 | United States |
| Synexus Clinical Research, Inc | Atlanta | Georgia | 30328 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | United States |
| Diamond Headache Clinic Ltd | Chicago | Illinois | 60642 | United States |
| JWM Neurology | Indianapolis | Indiana | 46256 | United States |
| Deaconess Clinic - Gateway Health Center | Newburgh | Indiana | 47630 | United States |
| PMG Research, Inc. d/b/a PMG Research of McFarland Clinic | Ames | Iowa | 50010 | United States |
| Heartland Research Associates, LLC | Newton | Kansas | 67114 | United States |
| College Park Family Care Center | Overland Park | Kansas | 66212 | United States |
| Collective Medical Research | Prairie Village | Kansas | 66208 | United States |
| Heartland Research Associates, LLC - An AMR Company | Wichita | Kansas | 67205 | United States |
| Heartland Research Associates, LLC - An AMR Company | Wichita | Kansas | 67207 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| John R. Graham Headache Center Brigham and Women's Faulkner Hospital | Boston | Massachusetts | 02103 | United States |
| BTC of New Bedford | New Bedford | Massachusetts | 02740 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| The Headache Center | Ridgeland | Mississippi | 39157 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest Research LLC | Springfield | Missouri | 65810 | United States |
| Synexus Clinical Research US, Inc. | Omaha | Nebraska | 68144 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | United States |
| PMG Research of Charlotte, LLC | Charlotte | North Carolina | 28209 | United States |
| Raleigh Neurology Associates, P.A. | Raleigh | North Carolina | 27607 | United States |
| PMG Research of Raleigh, LLC | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | United States |
| Wilmington Health, PLLC | Wilmington | North Carolina | 28401 | United States |
| Piedmont Medical Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Synexus Clinical Research US, Inc. | Akron | Ohio | 44311 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Patient Priority Clinical Sites | Cincinnati | Ohio | 45215 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43212 | United States |
| Ohio Clinical Research, LLC | Lyndhurst | Ohio | 44124 | United States |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 72069 | United States |
| Tulsa Clinical Research | Tulsa | Oklahoma | 74136 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | United States |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | United States |
| Preferred Primary Care Physicians, Jacob Murphy | Uniontown | Pennsylvania | 15401 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Partners in Clinical Research, LLC | Cumberland | Rhode Island | 02864 | United States |
| Ocean State Clinical Research Partners | Lincoln | Rhode Island | 02865 | United States |
| Primary Care Associates/Synexus Clinical | Anderson | South Carolina | 29621 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Hillcrest Family Practice | Simpsonville | South Carolina | 29681 | United States |
| ClinSearch | Chattanooga | Tennessee | 37421 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37760 | United States |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | United States |
| Psychiatry & Psychotherapy Partners Austin | Austin | Texas | 78737 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Synexus-US | Dallas | Texas | 75234 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Ventavia Research Group | Fort Worth | Texas | 76104 | United States |
| Centex Studies, Inc. | Houston | Texas | 77058 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Synexus Clinical Research, Inc | San Antonio | Texas | 78229 | United States |
| ClinPoint Trials | Waxahachie | Texas | 75165 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Synexus-US | Salt Lake City | Utah | 84123 | United States |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | United States |
| J. Lewis Research, Inc. | South Jordan | Utah | 84095 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | United States |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | United States |
| Sentara Neruology Specialists | Virginia Beach | Virginia | 23456 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Eastside Therapeutic Resource and Core Clinical Research | Everett | Washington | 98201 | United States |
| Puget Sound Neurology | Tacoma | Washington | 98409 | United States |
| 33942560 | Derived | Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4. |
| 33142014 | Derived | Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up 4 Weeks (Up to Week 44) |
|
|
Safety population included all participants who received at least 1 dose of atogepant in this extension study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, QD for up to 40 weeks. |
| 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 | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) | 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 included all participants who received at least 1 dose of atogepant in this extension study. | Posted | Number | percentage of participants | From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values 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. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported. | Safety population included all participants who received at least 1 dose of atogepant in this extension study. Number analyzed are participants with data available for analyses of the specific category. | Posted | Number | percentage of participants | Up to Week 44 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. | Safety population included all participants who received at least 1 dose of atogepant in this extension study. | Posted | Number | percentage of participants | Up to Week 40 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator | PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. | Safety population included all participants who received at least 1 dose of atogepant in this extension study. Number analyzed are participants with data available for analyses of the specific category. | Posted | Number | percentage of participants | Up to Week 44 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior. | Safety population included all participants who received at least 1 dose of atogepant in this extension study. One Safety population was used for the entire study. If participants were eligible for the Safety Follow-up they were included in the analyses even if they did not participate in the Safety Follow-up Period. | Posted | Count of Participants | Participants | OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44 |
|
From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, QD for up to 40 weeks. | 0 | 685 | 23 | 685 | 71 | 685 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Victim of abuse | Social circumstances | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
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 | Apr 30, 2021 | Mar 15, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718987 | atogepant |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| OG001 | Safety Follow-up Period | Following the open-label treatment period, participants entered the 4-week safety follow-up period. |
|
|