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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003448-58 | EudraCT Number |
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This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period. |
|
| Atogepant 60 mg | Active Comparator | Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atogepant 60 mg | Drug | Atogepant tablets. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axiom Research /ID# 226379 | Colton | California | 92324 | United States | ||
| Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434 |
| 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. | |
| 39715475 | Derived |
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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 315 participants were randomized to receive atogepant-matching placebo or atogepant in a double-blind treatment period, and 313 participants received at least 1 dose of study intervention (safety population). From the 295 participants who completed the double-blind period 87 participants entered the follow-up period. Participants who rolled over directly at Week 12 to study 3101-312-002 [NCT04686136] did not enter the safety-follow up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received atogepant-matching placebo tablets, orally, once daily (QD) for up to 12 weeks in a double-blind (DB) treatment period. |
| FG001 | Atogepant 60 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Treatment (Up to Week 12) |
|
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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 | Dec 1, 2020 | Aug 3, 2023 |
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| Drug |
Atogepant matching placebo tablets. |
|
| Baseline to Week 12 |
| Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population | 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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population | 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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. | Baseline to Week 12 |
| Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population | The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis. | Baseline to Week 12 |
| Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population | The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis. | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). | Baseline to Week 12 |
| Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). | Baseline to Week 12 |
| Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population | HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses. | Baseline to Week 12 |
| Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 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. TEAEs were defined as any AE with the onset that was after the first dose of study intervention. | From first dose of study drug until 30 days after last dose of study drug (up to Week 12) |
| Encino |
| California |
| 91316 |
| United States |
| Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388 | Los Alamitos | California | 90720-3500 | United States |
| Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405 | Los Alamitos | California | 90720-3500 | United States |
| Excell Research, Inc /ID# 228386 | Oceanside | California | 92056 | United States |
| Alpine Clinical Research Center /ID# 226201 | Boulder | Colorado | 80301-1880 | United States |
| Sensible Healthcare /ID# 226197 | Ocoee | Florida | 34761 | United States |
| Meridien Research /ID# 226224 | St. Petersburg | Florida | 33709 | United States |
| Meridien Research /ID# 226302 | St. Petersburg | Florida | 33709 | United States |
| Velocity Clinical Research - Boise /ID# 226320 | Meridian | Idaho | 83642 | United States |
| Allied Physicians - Fort Wayne Neurological Center /ID# 226350 | Fort Wayne | Indiana | 46804 | United States |
| Deaconess Clinic - Gateway Health Center /ID# 226481 | Newburgh | Indiana | 47630 | United States |
| Pharmasite Research, Inc. /ID# 226445 | Baltimore | Maryland | 21208 | United States |
| StudyMetrix Research /ID# 226297 | City of Saint Peters | Missouri | 63303 | United States |
| Clinvest Research LLC /ID# 226273 | Springfield | Missouri | 65807 | United States |
| Methodist Physicians Clinic /ID# 226470 | Fremont | Nebraska | 68025 | United States |
| Amici Clinical Research - Raritan /ID# 226282 | Raritan | New Jersey | 08869 | United States |
| Albuquerque Clinical Trials, Inc /ID# 233445 | Albuquerque | New Mexico | 87102 | United States |
| CTI Clinical Trial and Consulting /ID# 226281 | Cincinnati | Ohio | 45212 | United States |
| FutureSearch Trials of Neurology /ID# 226423 | Austin | Texas | 78731 | United States |
| Austin Clinical Trial Partners /ID# 228387 | Austin | Texas | 78737 | United States |
| DiscoveResearch, Inc /ID# 226491 | Bryan | Texas | 77802 | United States |
| FutureSearch Trials of Dallas, LP /ID# 226493 | Dallas | Texas | 75231 | United States |
| LinQ Research, LLC /ID# 226227 | Pearland | Texas | 77584 | United States |
| Highland Clinical Research /ID# 226288 | Salt Lake City | Utah | 84124 | United States |
| Northwest Clinical Research Center /ID# 226228 | Bellevue | Washington | 98007 | United States |
| Alfred Health /ID# 226341 | Melbourne | Victoria | 3004 | Australia |
| The Royal Melbourne Hospital /ID# 226402 | Parkville | Victoria | 3050 | Australia |
| Aggarwal and Associates Limited /ID# 226321 | Brampton | Ontario | L6T 0G1 | Canada |
| Ottawa Headache Centre Research Inc /ID# 226257 | Ottawa | Ontario | K2G 6E2 | Canada |
| Diex Recherche Sherbrooke Inc. /ID# 226375 | Sherbrooke | Quebec | J1L 0H8 | Canada |
| POLIKLINIKA CHOCEN, a.s. /ID# 226510 | Choceň | 565 01 | Czechia |
| BRAIN-SOULTHERAPY s.r.o. /ID# 226489 | Kladno | 272 01 | Czechia |
| CCR Ostrava, s.r.o. /ID# 226279 | Ostrava | 702 00 | Czechia |
| A-SHINE s.r.o. /ID# 226208 | Pilsen | 301 00 | Czechia |
| CLINTRIAL s.r.o. /ID# 226192 | Prague | 100 00 | Czechia |
| DADO MEDICAL s.r.o. /ID# 226548 | Prague | 120 00 | Czechia |
| CCR Prague s.r.o. /ID# 226214 | Prague | 130 00 | Czechia |
| CCR Czech a.s /ID# 226270 | Prague | 140 00 | Czechia |
| FORBELI s.r.o. /ID# 226396 | Prague | 160 00 | Czechia |
| INEP medical s.r.o. /ID# 226531 | Prague | 186 00 | Czechia |
| Vestra Clinics s.r.o. /ID# 226547 | Rychnov nad Kněžnou | 516 01 | Czechia |
| NeuroMed Zlin s.r.o. /ID# 226487 | Zlín | 760 01 | Czechia |
| Rigshospitalet Glostrup /ID# 226271 | Glostrup Municipality | Capital Region | 2600 | Denmark |
| CHU Nice - Hopital de Cimiez /ID# 226401 | Nice | Alpes-Maritimes | 06000 | France |
| CHU Lille /ID# 226501 | Lille | Nord | 59000 | France |
| CHU de SAINT ETIENNE - Hopital Nord /ID# 226397 | Saint Priest EN Jarez | Pays de la Loire Region | 42270 | France |
| CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438 | Clermont-Ferrand | 63000 | France |
| AP-HP - Hopital Lariboisière /ID# 226221 | Paris | 75010 | France |
| Universitaetsklinikum Tuebingen /ID# 226529 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441 | Berlin | 10117 | Germany |
| Klinische Forschung Dresden GmbH /ID# 226194 | Dresden | 01069 | Germany |
| Praxis Dr. Gendolla /ID# 226497 | Essen | 45133 | Germany |
| Universitaetsklinikum Essen /ID# 226527 | Essen | 45147 | Germany |
| Klinische Forschung Hannover-Mitte GmbH /ID# 226195 | Hanover | 30159 | Germany |
| Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439 | Jena | 07747 | Germany |
| Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767 | Kassel | 34131 | Germany |
| Schmerzklinik Kiel /ID# 226499 | Kiel | 24149 | Germany |
| AmBeNet GmbH /ID# 226213 | Leipzig | 04107 | Germany |
| Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202 | Mittweida | 09648 | Germany |
| Universitaetsmedizin Rostock /ID# 226517 | Rostock | 18057 | Germany |
| Neuropoint GmbH /ID# 226377 | Ulm | 89073 | Germany |
| Neuropraxis Muenchen Sued /ID# 226216 | Unterhaching | 82008 | Germany |
| Studienzentrum Nord-West /ID# 226360 | Westerstede | 26655 | Germany |
| Intermed GmbH /ID# 226376 | Wiesbaden | 65189 | Germany |
| DKD Helios Klinik Wiesbaden /ID# 226534 | Wiesbaden | 65191 | Germany |
| Bugat Pal Korhaz /ID# 226357 | Gyöngyös | Heves County | 3200 | Hungary |
| Valeomed Kft /ID# 226535 | Esztergom | Komárom-Esztergom | 2500 | Hungary |
| Szent Borbala Korhaz /ID# 226400 | Tatabánya | Komárom-Esztergom | 2800 | Hungary |
| Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485 | Kaposvár | Somogy County | 7400 | Hungary |
| Mind Klinika Kft. /ID# 233438 | Budapest | 1024 | Hungary |
| Clinexpert Kft /ID# 226467 | Budapest | 1033 | Hungary |
| Department of Neurology, University of Szeged /ID# 226442 | Szeged | 6725 | Hungary |
| Ospedale Ss. Filippo e Nicola /ID# 226530 | Avezzano | L Aquila | 67051 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361 | Rome | Lazio | 00128 | Italy |
| Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475 | Bologna | 40126 | Italy |
| Azienda Ospedaliero Universitaria Careggi /ID# 226502 | Florence | 50134 | Italy |
| Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399 | Milan | 20133 | Italy |
| AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503 | Naples | 80138 | Italy |
| Universita di Pavia /ID# 226536 | Pavia | 27100 | Italy |
| Martini Ziekenhuis /ID# 226343 | Groningen | 9728 NT | Netherlands |
| Canisius-Wilhelmina Ziekenhuis /ID# 226488 | Nijmegen | 6532 SZ | Netherlands |
| ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317 | Terneuzen | 4535 PA | Netherlands |
| Solumed Centrum Medyczne /ID# 226299 | Poznan | Greater Poland Voivodeship | 60-529 | Poland |
| NZOZ Vitamed /ID# 226293 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Specjalistyczne Gabinety Sp. z o.o. /ID# 226266 | Krakow | Lesser Poland Voivodeship | 30-539 | Poland |
| Centrum Leczenia Padaczki i Migreny /ID# 226543 | Krakow | Lesser Poland Voivodeship | 31-209 | Poland |
| Centrum Medyczne Oporow /ID# 226469 | Wroclaw | Lower Silesian Voivodeship | 52-416 | Poland |
| Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235 | Lublin | Lublin Voivodeship | 20-582 | Poland |
| Duplicate_RCMed Oddzial Sochaczew /ID# 226369 | Sochaczew | Masovian Voivodeship | 96-500 | Poland |
| Centrum Medyczne Pratia Gdynia /ID# 226437 | Gdynia | Pomeranian Voivodeship | 81-338 | Poland |
| Silmedic Sp. z o.o. /ID# 226267 | Katowice | Silesian Voivodeship | 40-282 | Poland |
| EuroMedis sp. z o.o. /ID# 226268 | Szczecin | West Pomeranian Voivodeship | 70-111 | Poland |
| Gabinet Lekarski Jacek Rozniecki /ID# 226323 | Lodz | Łódź Voivodeship | 90-338 | Poland |
| Bashkir State Medical University /ID# 226552 | Ufa | Bashkortostan Republic | 450005 | Russia |
| Kazan State Medical University /ID# 226498 | Kazan' | Tatarstan, Respublika | 420012 | Russia |
| Sbhi Cp 2 Hdm /Id# 226494 | Moscow | 117556 | Russia |
| University Headache Clinic /ID# 226435 | Moscow | 119221 | Russia |
| Cephalgolog /ID# 226541 | Moscow | 125040 | Russia |
| Hospital Unversitario Marques de Valdecilla /ID# 226239 | Santander | Cantabria | 39008 | Spain |
| University Clinical Hospital of Valladolid /ID# 226528 | Valledolid | Castellon | 47005 | Spain |
| Hospital Universitario Vall d'Hebron /ID# 226230 | Barcelona | 08035 | Spain |
| Hospital Santa Creu i Sant Pau /ID# 226550 | Barcelona | 08041 | Spain |
| Hospital Clinico Universitario San Carlos /ID# 226483 | Madrid | 28040 | Spain |
| Hospital Clinico Universitario de Valencia /ID# 226472 | Valencia | 46010 | Spain |
| Hospital Clinico Universitario Lozano Blesa /ID# 226395 | Zaragoza | 50009 | Spain |
| Karolinska university hospital, Huddinge /ID# 226215 | Huddinge | Stockholm County | 141 86 | Sweden |
| Queen Elizabeth University Hospital /ID# 226492 | Glasgow | G51 4TF | United Kingdom |
| Re:Cognition Health - Guildford /ID# 226539 | Guildford | GU2 7YD | United Kingdom |
| NHS Highland /ID# 226542 | Inverness | IV2 3UJ | United Kingdom |
| Leeds Teaching Hospitals NHS Trust /ID# 226538 | Leeds | LS9 7TF | United Kingdom |
| St Pancras Clinical Research /ID# 226551 | London | EC2Y 8EA | United Kingdom |
| King's College Hospital NHS Foundation Trust /ID# 226525 | London | SE5 9RS | United Kingdom |
| Re:Cognition Health - London /ID# 226540 | London | W1G 9JF | United Kingdom |
| Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23. |
| 39648617 | Derived | Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305. |
| 38364831 | Derived | Tassorelli C, Nagy K, Pozo-Rosich P, Lanteri-Minet M, Sacco S, Nezadal T, Guo H, De Abreu Ferreira R, Forero G, Trugman JM. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Apr;23(4):382-392. doi: 10.1016/S1474-4422(24)00025-5. Epub 2024 Feb 13. |
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
| Safety Population | Safety population consisted of all participants who received at least 1 dose of study intervention. |
|
| Modified Intent-to-Treat (mITT) Population | mITT population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, and 9 to 12) of eDiary data during the double-blind treatment period. |
|
| Off-treatment Hypothetical Estimand (OTHE) Population | OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Follow-up Period (Week 13 to Week 16) |
|
|
Intent-to-Treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period. |
| BG001 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. |
| BG002 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Monthly Migraine Days in mITT Population | A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (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. | mITT population included all randomized participants who received at least 1 dose of study intervention. | Mean | Standard Deviation | Migraine days per month |
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| Monthly Migraine Days in OTHE Population | A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (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. | OTHE population consisted of all randomized participants who received at least 1 dose of study intervention, had an evaluable baseline period of eDiary data, and had at least 1 evaluable postbaseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study intervention or off study intervention. | Mean | Standard Deviation | Migraine days per month |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) was used for analysis. | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. | Posted | Least Squares Mean | Standard Error | migraine days per month | Baseline to Week 12 |
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| Primary | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population | Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. | Posted | Least Squares Mean | Standard Error | migraine days per month | Baseline to Week 12 |
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| Secondary | Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in mITT Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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. | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. | Posted | Count of Participants | Participants | Baseline to Week 12 |
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| Secondary | Number of Participants With At Least a 50% Reduction in 3-Month Average of Monthly Migraine Days Across the 12-week Treatment Period in OTHE Population | Data is reported for 50% responders averaged at each 4-week period. 50% responders are participants with at least a 50% reduction from baseline in 3-month average of monthly migraine days. Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache. The monthly (4-week) migraine days are equal to 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. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. | Posted | Count of Participants | Participants | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in mITT Population | 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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. | Posted | Least Squares Mean | Standard Error | headache days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Headache Days Across the 12-week Treatment Period in OTHE Population | 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 pain lasting 2 hours or longer unless an acute headache medication was used after the start of the headache. The monthly (4-week) headache days were 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. Baseline is defined as the number of headache days during the last 28 days prior to the randomization date. Negative change from Baseline indicates improvement. MMRM was used for analysis. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. | Posted | Least Squares Mean | Standard Error | headache days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in mITT Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. 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 eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. | Posted | Least Squares Mean | Standard Error | acute medication use days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-week Treatment Period in OTHE Population | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) to treat an acute migraine. The monthly (4-week) acute medication use days were 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. Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A negative change from Baseline indicates improvement. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. | Posted | Least Squares Mean | Standard Error | acute medication use days per month | Baseline to Week 12 |
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| Secondary | Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in mITT Population | The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis. | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed are the number of participants available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in Migraine Specific Quality of Life Questionnaire (MSQ) v2.1 Role Function-Restrictive Domain Score at Week 12 in OTHE Population | The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive (question numbers 1-7, score ranges 7 to 42) assesses how migraines limit one's daily social and work-related activities; Role Function Preventive (question numbers 8-11, score ranges 4 to 24) assesses how migraines prevent these activities; and the Emotional Function (question numbers 12-14, score ranges 3 to 18) domain assesses the emotions associated with migraines. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. MMRM was used for analysis. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) Across the 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item patient-reported outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities which include, 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw performance of daily activities domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across the 12-Week Treatment Period in mITT Population | The AIM-D is a 11-item PRO measure that assesses the impact of migraine on the performance of daily activities which includes 7 items: difficulty with household chores, errands, leisure activities at home, leisure or social activities outside the home, strenuous physical activities, concentrating, and thinking clearly and physical impairment; 4 items: difficulty walking, moving body, bending forward, moving head using a 6-point rating scale where 0=not difficult at all, 1=a little difficult, 2=somewhat difficult, 3=very difficult, 4=extremely difficult, and 5=I could not do it at all. The raw physical impairment domain scores were transformed to 0-100 scale, with higher scores indicating greater impact of migraine (higher disease burden). | mITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data, and had at least 1 evaluable post-baseline 4-week period of eDiary data during the double-blind treatment period. Overall number of participants analyzed is the number of participants available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 12 |
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| Secondary | Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in OTHE Population | HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always). MMRM was used for the analyses. | OTHE Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of eDiary data and had at least 1 evaluable post-baseline 4-week period (Weeks 1 to 4, 5 to 8, 9 to 12) of eDiary data, regardless of whether on study treatment or off study treatment. Overall number of participants analyzed is the number of participants available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 12 |
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| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 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. TEAEs were defined as any AE with the onset that was after the first dose of study intervention. | Safety population consisted of all participants who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From first dose of study drug until 30 days after last dose of study drug (up to Week 12) |
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All cause mortality is reported from enrollment to end of study; median time on follow up was 93.5 and 90.0 days for Placebo and Atogepant, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was 83.7 days and 81.7 days for Placebo and Atogepant, respectively.
All-cause mortality is reported for all participants enrolled in the study. Serious and other adverse events are reported for Safety population which consisted of all participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Placebo | Participants received atogepant-matching placebo tablets, orally, QD for up to 12 weeks in a DB treatment period. | 0 | 158 | 0 | 157 | 34 | 157 |
| EG001 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. | 0 | 157 | 4 | 156 | 40 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| BREAST CANCER STAGE II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| INVASIVE BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA 24.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | 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 | Aug 21, 2022 | Aug 3, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
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| C000718987 | atogepant |
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Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. |
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| OG001 | Atogepant 60 mg | Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. |
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| Atogepant 60 mg |
Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period. |
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Participants received atogepant 60 mg, orally, QD for up to 12 weeks in a DB treatment period.
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