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Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine.
Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States.
Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks.
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 + Ubrogepant | Experimental | Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Oral Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 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. A treatment-emergent adverse event (TEAE) is an AE that occurs or worsens after receiving investigational study drug. | From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks) |
| 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. | Up to approximately 28 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. 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 approximately 24 weeks |
| Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator |
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Inclusion Criteria:
Exclusion Criteria:
- Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC /ID# 244912 | Birmingham | Alabama | 35216 | United States | ||
| Xenoscience, Inc /ID# 243506 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39569702 | Derived | Ailani J, Lipton RB, Blumenfeld AM, Mechtler L, Klein BC, He MY, Smith JH, Trugman JM, de Abreu Ferreira R, Brand-Schieber E. Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study. Headache. 2025 Jun;65(6):1005-1014. doi: 10.1111/head.14871. Epub 2024 Nov 21. |
| 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, 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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
A total of 263 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant withdrew consent before receiving study drug and therefore was not included in the demographics or any analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atogepant 60 mg (Period 1) | Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1. |
| FG001 | Atogepant 60 mg + Ubrogepant 100 mg (Period 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 Atogepant (Day1 to Wk12) |
|
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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 | Jul 22, 2022 | Apr 1, 2024 |
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| Ubrogepant | Drug | Oral Tablet |
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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 approximately 28 weeks |
| Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal 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. | Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2 |
| Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period | C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal 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. | From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days. |
| Phoenix |
| Arizona |
| 85004 |
| United States |
| Excell Research, Inc /ID# 242590 | Oceanside | California | 92056 | United States |
| Neurological Research Institute /ID# 244161 | Santa Monica | California | 90404 | United States |
| George J. Rederich M.D. Inc. /ID# 242589 | Torrance | California | 90505 | United States |
| Diablo Clinical Research /ID# 242592 | Walnut Creek | California | 94598 | United States |
| Westside Center for Clinical Research /ID# 243287 | Jacksonville | Florida | 32205-4785 | United States |
| Suncoast Clinical Research /ID# 242463 | New Port Richey | Florida | 34652 | United States |
| Meridien Research /ID# 243508 | Orlando | Florida | 32810 | United States |
| Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091 | St. Petersburg | Florida | 33709-3113 | United States |
| Meridian Clinical Research (Neurology) - Savannah /ID# 242689 | Savannah | Georgia | 31406-2758 | United States |
| Clinical Research Atlanta - Headlands LLC /ID# 242661 | Stockbridge | Georgia | 30281-9054 | United States |
| Allied Physicians - Fort Wayne Neurological Center /ID# 243511 | Fort Wayne | Indiana | 46804 | United States |
| Pharmasite Research, Inc. /ID# 243505 | Baltimore | Maryland | 21208 | United States |
| Medstar Georgetown Neurology /ID# 243289 | Chevy Chase | Maryland | 20815 | United States |
| QUEST Research Institute /ID# 243284 | Farmington Hills | Michigan | 48334-2977 | United States |
| Clinvest Research LLC /ID# 242597 | Springfield | Missouri | 65807 | United States |
| Princeton Center for Clinical Research /ID# 242652 | Skillman | New Jersey | 08558 | United States |
| Bio Behavioral Health, Inc /ID# 242643 | Toms River | New Jersey | 08755-6434 | United States |
| Dent Neurosciences Research Center, Inc. /ID# 242641 | Amherst | New York | 14226 | United States |
| Central New York Clinical Research /ID# 242593 | Manlius | New York | 13104 | United States |
| Rochester Clinical Research /ID# 242470 | New York | New York | 14609 | United States |
| PMG Research of Raleigh LLC /ID# 243286 | Raleigh | North Carolina | 27609 | United States |
| CTI Clinical Trial and Consulting /ID# 242884 | Cincinnati | Ohio | 45212 | United States |
| Aventiv Research Columbus /ID# 242462 | Columbus | Ohio | 43213 | United States |
| The Orthopedic Foundation /ID# 243292 | New Albany | Ohio | 43054-8167 | United States |
| Summit Research Network /ID# 242467 | Portland | Oregon | 97210 | United States |
| Abington Neurological Associates - Abington /ID# 243291 | Abington | Pennsylvania | 19001 | United States |
| WR-ClinSearch /ID# 242640 | Chattanooga | Tennessee | 37421-1605 | United States |
| FutureSearch Trials of Neurology /ID# 242690 | Austin | Texas | 78731 | United States |
| DiscoveResearch, Inc /ID# 242469 | Bryan | Texas | 77802 | United States |
| FutureSearch Trials of Dallas, LP /ID# 242658 | Dallas | Texas | 75231 | United States |
| Protenium Clinical Research /ID# 244067 | Hurst | Texas | 76054 | United States |
| ClinPoint Trials /ID# 242660 | Waxahachie | Texas | 75165-1430 | United States |
| Advanced Research Institute - Ridgeline /ID# 242662 | Ogden | Utah | 84405-6779 | United States |
| Highland Clinical Research /ID# 245159 | Salt Lake City | Utah | 84124 | United States |
| Core Clinical Research /ID# 244436 | Everett | Washington | 98201 | United States |
Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2.
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 Atogepant+Ubrogepant (Wk12-24) |
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Overall safety population included all participants who received at least 1 dose of study drug. 263 participants were enrolled, but one participant withdrew consent prematurely discontinuing from the study before receiving study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1 then atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. 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. A treatment-emergent adverse event (TEAE) is an AE that occurs or worsens after receiving investigational study drug. | Safety Population 1 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant treatment period) and Safety Population 2 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period). | Posted | Count of Participants | Participants | From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks) |
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| |||||||||||||||||||||||||||||
| Primary | 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 1 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant treatment period) and Safety Population 2 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period). | Posted | Number | participants | Up to approximately 28 weeks |
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| 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. 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 1 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant treatment period) and Safety Population 2 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period). | Posted | Number | participants | Up to approximately 24 weeks |
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| Primary | 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 1 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant treatment period) and Safety Population 2 (all subjects who received ≥ 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period). | Posted | Number | participants | Up to approximately 28 weeks |
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| Primary | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period | C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal 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 1 consisted of all subjects who received at least 1 dose of study drug during the open-label atogepant treatment period as well as Safety Population 2 consisted of all subjects who went on to receive at least 1 dose of study drug during the open-label atogepant + ubrogepant concomitant-use treatment period. The one subject with positive suicidal behavior was erroneously reported in the questionnaire and had not had a positive suicidal behavior throughout the study. | Posted | Number | participants | Week 1 to Week 12 for Safety Population 1; Week 12 to Week 24 for Safety Population 2 |
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| Primary | Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) During the 4-Week Safety Follow-Up Period | C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and suicidal 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 1 consisted of all subjects who received at least 1 dose of study drug during the open-label atogepant treatment period. The statistical analysis plan (SAP) does not include the Safety Population 2 (all subjects who received at least 1 dose of study drug in Period 2) subgroup analyses for this primary outcome measure. | Posted | Number | participants | From last dose of study drug to 4 weeks after last dose of study drug. Overall median time on atogepant treatment was 85 days. |
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All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 75.5 days from Visit 1 (Week -1) through end of Period 1 and 206 days from baseline through end of Period 2.
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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 | Atogepant 60 mg (Period 1) | Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1. | 0 | 263 | 1 | 263 | 66 | 263 |
| EG001 | Atogepant 60 mg + Ubrogepant 100 mg (Period 2) | Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2. | 0 | 218 | 1 | 218 | 15 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MYELOPATHY | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| URETEROLITHIASIS | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 25.0 | 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 | Dec 7, 2022 | Apr 1, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
| C000615620 | ubrogepant |
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| 40 to 49 years |
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| 50 to 59 years |
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| 60 to 69 years |
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| ≥ 70 years |
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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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| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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Participants will receive atogepant 60 mg tablets orally once daily for 12 weeks (Day 1 to Week 12) in Period 1. |
| OG001 | Atogepant 60 mg + Ubrogepant 100 mg (Period 2) | Participants will receive atogepant 60 mg tablets orally once daily and ubrogepant 100 mg tablets orally as needed for an additional 12 weeks (Week 12 to Week 24) in Period 2. |
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