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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513836-28 | |||
| 2024-513836-28-00 | EU Trial (CTIS) Number |
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Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.
Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atogepant | Experimental | Participants will receive atogepant once daily for 12 weeks. |
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| Placebo for Atogepant | Placebo Comparator | Participants will receive placebo for atogepant once daily 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 Experiencing Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 16 weeks |
| Change From Baseline in Mean Monthly Migraine Days | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. | Baseline (Week 0) through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Monthly Headache Days | A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM. | Baseline (Week 0) through Week 12 |
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Inclusion Criteria:
History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
During the last 28 days of the screening/baseline period, and as per eDiary:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation and Neurological Services /ID# 270782 | Recruiting | Huntsville | Alabama | 35805 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41235617 | Derived | Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14. |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo for Atogepant | Drug | Oral tablet |
|
| Change From Baseline in Mean Monthly Acute Medication Use Days | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine. | Baseline (Week 0) through Week 12 |
| Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days | A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM. | Baseline (Week 0) through Week 12 |
| Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score | The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score. | Baseline (Week 0) through Week 12 |
| Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score | The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions. | Baseline (Week 0) through Week 12 |
| Preferred Research Partners - Fayetteville /ID# 270419 |
| Completed |
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Preferred Research Partner, Inc /ID# 270389 | Recruiting | Little Rock | Arkansas | 72211 | United States |
| Advanced Research Center /ID# 270257 | Recruiting | Anaheim | California | 92805 | United States |
| Neuro Pain Research Center /ID# 271048 | Recruiting | Fresno | California | 93710 | United States |
| Accellacare - Long Beach /ID# 270398 | Recruiting | Long Beach | California | 90807 | United States |
| Excell Research /ID# 270258 | Recruiting | Oceanside | California | 92056 | United States |
| Lumos Clinical Research Center /ID# 270582 | Recruiting | San Jose | California | 95124 | United States |
| Sunwise Clinical Research /ID# 270431 | Recruiting | Walnut Creek | California | 94596 | United States |
| Northwest Florida Clinical Research Group, LLC /ID# 270833 | Recruiting | Gulf Breeze | Florida | 32561 | United States |
| Auzmer Research /ID# 271158 | Completed | Lakeland | Florida | 33813 | United States |
| My Preferred Research /ID# 270312 | Recruiting | Miami | Florida | 33155 | United States |
| Encore Medical Research - Weston /ID# 271139 | Recruiting | Weston | Florida | 33331 | United States |
| Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 | Recruiting | Winter Park | Florida | 32789 | United States |
| Deaconess Midtown Hospital /ID# 270572 | Recruiting | Evansville | Indiana | 47710 | United States |
| Michigan Headache & Neurological Institute /ID# 270942 | Recruiting | Ann Arbor | Michigan | 48104 | United States |
| Proven Endpoints LLC /ID# 270269 | Recruiting | Ridgeland | Mississippi | 39157 | United States |
| Cct Research - Papillion Research Center /ID# 270393 | Recruiting | Papillion | Nebraska | 68046 | United States |
| Healthy Perspectives - Innovate Mental Health Services /ID# 270847 | Recruiting | Nashua | New Hampshire | 03060 | United States |
| Dent Neurologic Institute - Amherst /ID# 270260 | Recruiting | Amherst | New York | 14226 | United States |
| Headache Wellness Center /ID# 270568 | Recruiting | Greensboro | North Carolina | 27405 | United States |
| Frontier Clinical Research - Scottdale /ID# 270854 | Recruiting | Scottdale | Pennsylvania | 15683 | United States |
| Frontier Clinical Research - Smithfield /ID# 270849 | Recruiting | Smithfield | Pennsylvania | 15478 | United States |
| Access Clinical Trials Inc /ID# 270280 | Recruiting | Nashville | Tennessee | 37203 | United States |
| UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577 | Recruiting | Austin | Texas | 78723-3079 | United States |
| Earle Research /ID# 270424 | Recruiting | Houston | Texas | 77058 | United States |
| Clinpoint Trials /ID# 270261 | Recruiting | Waxahachie | Texas | 75165 | United States |
| Pantheon Clinical Research /ID# 270259 | Recruiting | Bountiful | Utah | 84010 | United States |
| Alpine Research Organization - Clinton /ID# 276527 | Recruiting | Clinton | Utah | 84015 | United States |
| Highland Clinical Research /ID# 270281 | Recruiting | Salt Lake City | Utah | 84124 | United States |
| Frontier Clinical Research - Kingwood /ID# 271053 | Recruiting | Kingwood | West Virginia | 26537 | United States |
| London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659 | Recruiting | London | Ontario | N6A 5W9 | Canada |
| McGill University Health Centre - Glen Site. /ID# 270662 | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
| Herlev Hospital /ID# 270482 | Recruiting | Herlev | Capital Region | 2730 | Denmark |
| Regionshospitalet Godstrup /ID# 270481 | Recruiting | Herning | Central Jutland | 7400 | Denmark |
| Semmelweis Egyetem /ID# 271219 | Recruiting | Budapest | 1085 | Hungary |
| Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500 | Recruiting | Budapest | 1141 | Hungary |
| Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756 | Recruiting | Milan | Milano | 20133 | Italy |
| Ospedale Pediatrico Bambino Gesù /ID# 270759 | Recruiting | Rome | Roma | 00165 | Italy |
| Konan Medical Center /ID# 270486 | Recruiting | Kobe | Hyōgo | 658-0064 | Japan |
| Umenotsuji Clinic /ID# 270484 | Recruiting | Kochi | Kochi | 780-8011 | Japan |
| Tominaga Clinic - Osaka /ID# 270483 | Recruiting | Osaka | Osaka | 556-0015 | Japan |
|
| Tokyo Headache Clinic /ID# 271610 | Recruiting | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Tokyo Medical University Hospital /ID# 270487 | Recruiting | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Tendo Brain Clinic /ID# 271410 | Recruiting | Tendo-shi | Yamagata | 994-0083 | Japan |
| Nagaseki Headache Clinic /ID# 271699 | Recruiting | Kai | Yamanashi | 400-0124 | Japan |
| Tanaka Neurosurgery & Headache Clinic /ID# 271346 | Recruiting | Kagoshima | 890-0052 | Japan |
| Canisius-Wilhelmina Ziekenhuis /ID# 270374 | Recruiting | Nijmegen | Gelderland | 6532 SZ | Netherlands |
| HagaZiekenhuis /ID# 270379 | Recruiting | The Hague | South Holland | 2545 AA | Netherlands |
| Clinical Research Center Medic-R /ID# 270235 | Recruiting | Poznan | Greater Poland Voivodeship | 60-848 | Poland |
| Athleticomed Sp. z o.o /ID# 270243 | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-752 | Poland |
| Specjalistyczne Gabinety Sp. z o.o /ID# 270238 | Recruiting | Krakow | Lesser Poland Voivodeship | 30-539 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny /ID# 270239 | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| Oha-Med Sp. Z O.O /ID# 270242 | Recruiting | Warsaw | Masovian Voivodeship | 01-018 | Poland |
| Hospital da Luz /ID# 277991 | Recruiting | Lisbon | Lisbon District | 1500-650 | Portugal |
| Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092 | Recruiting | Almada | Setúbal District | 2805-267 | Portugal |
|
| Unidade Local de Saude de Coimbra /ID# 277993 | Recruiting | Coimbra | 3000-075 | Portugal |
| Unidade Local de Saude de Santa Maria /ID# 277997 | Recruiting | Lisbon | 1649-035 | Portugal |
| Unidade Local de Saude de Santo Antonio /ID# 278090 | Recruiting | Porto | 4099-003 | Portugal |
| CMRC Headlands LLC /ID# 271300 | Recruiting | San Juan | 00918-3501 | Puerto Rico |
| Great Ormond Street Children's Hospital /ID# 271550 | Recruiting | London | Greater London | WC1N 3HZ | United Kingdom |
| Medway Maritime Hospital /ID# 271885 | Recruiting | Gillingham | Kent | ME7 5NY | United Kingdom |
| Royal Aberdeen Children's Hospital /ID# 271664 | Recruiting | Aberdeen | Scotland | AB25 2ZG | United Kingdom |
| Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883 | Recruiting | Stockport | SK2 7JE | United Kingdom |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000718987 | atogepant |
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