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This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo-matching atogepant capsule orally twice daily in the morning and in the evening for 12 weeks. |
|
| Atogepant 10 mg QD | Experimental | Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
|
| Atogepant 30 mg QD | Experimental | Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
|
| Atogepant 30 mg BID | Experimental | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
|
| Atogepant 60 mg QD | Experimental | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant | Drug | Atogepant capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. |
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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 |
|---|---|---|---|---|---|---|
| Achieve Clinical Research | Birmingham | Alabama | 35216 | United States | ||
| Radiant Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39982105 | Derived | Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610. | |
| 39648629 | Derived |
| Label | URL |
|---|---|
| http://www.allerganclinicaltrials.com | View source |
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Participants diagnosed with migraine, with or without aura were enrolled in one of 6 treatment arms: placebo, or atogepant 10 mg once daily (QD), 30 mg QD, 60 mg QD, 30 mg twice daily (BID), or 60 mg BID.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks. |
| FG001 | Atogepant 10 mg QD | Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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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 11, 2017 | Nov 13, 2018 |
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| Atogepant 60 mg BID | Experimental | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
|
|
| Placebo-matching Atogepant | Drug | Placebo-matching atogepant capsule. |
|
| Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period | Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement. | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| Chandler |
| Arizona |
| 85224 |
| United States |
| The Research Center of Southern California, LLC | Carlsbad | California | 92011 | United States |
| Neuro-Pain Medical Center, Inc | Fresno | California | 93710 | United States |
| Irvine Center for Clinical Research | Irvine | California | 92618 | United States |
| Downtown LA Research Center, Inc. | Los Angeles | California | 90017 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| Diablo Clinical Research Inc | Walnut Creek | California | 94598 | United States |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | United States |
| Hartford Headache Center | East Hartford | Connecticut | 06118 | United States |
| Associated Neurologists of Southern Connecticut, P. C. | Fairfield | Connecticut | 06824 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| The George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Clinical Research South Florida | Coral Gables | Florida | 33134 | United States |
| Infinity Clinical Research | Hollywood | Florida | 33021 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Clinical Neuroscience Solutions Inc | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Suncoast Research | Miami | Florida | 33135 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | United States |
| Palm Beach Neurological Center / Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida | 33410 | United States |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33713 | United States |
| Infinity Clinical Research LLC | Sunrise | Florida | 33351 | United States |
| Meridien Research | Tampa | Florida | 33634 | United States |
| Neurology Research Institute Palm Beach | West Palm Beach | Florida | 33407 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Radiant Research | Atlanta | Georgia | 30328 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) Neurology | Sandy Springs | Georgia | 30328 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Northwest Clinical Trials, Inc. | Boise | Idaho | 83704 | United States |
| Healthcare Research Network II, LLC | Blue Island | Illinois | 60406 | United States |
| Rowe Neurology Institute | Lenexa | Kansas | 66214 | United States |
| Boston Clinical Trials Inc | Boston | Massachusetts | 02131 | United States |
| Northeast Medical Research Associates, Inc. | North Dartmouth | Massachusetts | 02747 | United States |
| Medvadis Research Corporation | Watertown | Massachusetts | 02472 | United States |
| New England Regional Headache Center | Worcester | Massachusetts | 01605 | United States |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Mercy Research | Springfield | Missouri | 65806 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Quality Clinical Research, Inc | Omaha | Nebraska | 68114 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Renown Institute for Neuroscience | Reno | Nevada | 89502 | United States |
| Hassman Research Institute - NJ | Berlin | New Jersey | 08009 | United States |
| Amici Clinical Research | Warren Township | New Jersey | 07059 | United States |
| DENT Neurosciences Research Center | Amherst | New York | 14226 | United States |
| Radiant Research, Inc. | Jamaica | New York | 11432 | United States |
| Carolina Headache Institute | Durham | North Carolina | 27713 | United States |
| Wake Research Associates LLC | Raleigh | North Carolina | 27612 | United States |
| Ohio Clinical Research, LLC | Willoughby Hills | Ohio | 44094 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Center for Clinical Investigations, Inc. | Salem | Oregon | 97301 | United States |
| Lehigh Center For Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Cns Healthcare | Memphis | Tennessee | 38119 | United States |
| Nashville Neuroscience Group | Nashville | Tennessee | 37203 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| DermResearch Inc | Austin | Texas | 78759 | United States |
| DiscoveResearch, Inc. | Bryan | Texas | 77802 | United States |
| Synexus US, L.P. Formally known as Texas Pharmaceutical Research, LP, DBA Research Across America | Dallas | Texas | 75234 | United States |
| Central Texas Neurology Consultant | Round Rock | Texas | 78681 | United States |
| Radiant Research, San Antonio Center for Clinical Research | San Antonio | Texas | 78229 | United States |
| Road Runner Research LTD | San Antonio | Texas | 78258 | United States |
| ClinPoint Trials, LLC | Waxahachie | Texas | 75165 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| Kingfisher Cooperative, LLC | Spokane | Washington | 99202 | United States |
| 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. |
| 32822633 | Derived | Goadsby PJ, Dodick DW, Ailani J, Trugman JM, Finnegan M, Lu K, Szegedi A. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020 Sep;19(9):727-737. doi: 10.1016/S1474-4422(20)30234-9. |
| FG002 | Atogepant 30 mg QD | Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| FG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| FG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| FG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| Safety Population: Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up Period |
|
|
Safety Population included all participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks. |
| BG001 | Atogepant 10 mg QD | Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| BG002 | Atogepant 30 mg QD | Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| BG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| BG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| BG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| BG006 | Total | Total of all reporting groups |
| 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 |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Migraine Days (Migraine/Probable Migraine Headache Days) | A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. | Modified-intent-to-treatment (mITT) Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data. | Mean | Standard Deviation | migraine days per month |
|
| 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 | Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. | MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data. | Posted | Least Squares Mean | Standard Error | migraine days per month | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period | Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement. | MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data. | Posted | Least Squares Mean | Standard Error | headache days per month | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged. | MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data. | Posted | Number | percentage of participants | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period | Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement. | MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data. | Posted | Least Squares Mean | Standard Error | acute medication use days per month | Baseline (First 28 Days of Screening/Baseline Period) to Week 12 |
|
Up to Week 16
Safety population, all randomized participants who received at least 1 dose of study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
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 | Placebo | Placebo-matching atogepant capsules orally twice daily in the morning and in the evening for 12 weeks. | 0 | 186 | 2 | 186 | 36 | 186 |
| EG001 | Atogepant 10 mg QD | Atogepant 10 mg capsule orally once daily (QD) in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. | 0 | 93 | 1 | 93 | 17 | 93 |
| EG002 | Atogepant 30 mg QD | Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. | 0 | 183 | 2 | 183 | 47 | 183 |
| EG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. | 0 | 186 | 2 | 186 | 52 | 186 |
| EG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. | 0 | 86 | 0 | 86 | 21 | 86 |
| EG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. | 0 | 91 | 0 | 91 | 26 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ureteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 20.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Overdose | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2018 | Nov 13, 2018 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718987 | atogepant |
Not provided
Not provided
Not provided
| Lost to Follow-up |
|
|
|
|
| Black or African American |
|
|
| Asian |
|
|
| American Indian or Alaska Native |
|
|
| Native Hawaiian/Other Pacific Islander |
|
|
| Multiple Races |
|
|
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| Not Hispanic or Latino |
|
|
|
| MMRM |
| 0.0056 |
MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms. |
| Least squares mean difference |
| -0.91 |
| Standard Error of the Mean |
| 0.33 |
| 2-Sided |
| 95 |
| -1.55 |
| -0.27 |
| Superiority |
| MMRM | 0.0325 | MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms. | Least squares mean difference | -0.70 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -1.35 | -0.06 | Superiority |
| MMRM | 0.0010 | MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms. | Least squares mean difference | -1.39 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -2.21 | -0.56 | Superiority |
| MMRM | 0.0016 | MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms. | Least squares mean difference | -1.29 | Standard Error of the Mean | 0.41 | 2-Sided | 95 | -2.09 | -0.49 | Superiority |
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| OG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| OG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| OG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
|
|
|
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks. |
| OG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| OG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| OG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
|
|
|
Atogepant 30 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally once daily in the evening for 12 weeks.
| OG003 | Atogepant 60 mg QD | Atogepant 60 mg capsule orally once daily in the morning and one placebo-matching atogepant capsule orally in the evening for 12 weeks. |
| OG004 | Atogepant 30 mg BID | Atogepant 30 mg capsule orally twice daily (BID); 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
| OG005 | Atogepant 60 mg BID | Atogepant 60 mg capsule orally twice daily; 1 capsule in the morning and 1 capsule in the evening for 12 weeks. |
|
|
|