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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508821-28-00 | Other Identifier | EU Trial |
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The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Placebo SC (closed for recruitment) | Placebo Comparator | Participants will receive 2 injections of placebo. |
|
| Group B: Lu AG09222 SC (closed for recruitment) | Experimental | Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. |
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| Group C: Lu AG09222 SC (closed for recruitment) | Experimental | Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. |
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| Group D: Lu AG09222 SC (closed for recruitment) | Experimental | Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. |
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| Group E: Lu AG09222 SC (closed for recruitment) | Experimental | Participants will receive 2 injections, each containing Lu AG09222. |
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| Group F: Placebo IV |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG09222 | Drug | Lu AG09222 will be administered per the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Monthly Migraine Days (MMDs) | Baseline up to Week 12 (Weeks 1-12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MMDs | Baseline up to Week 12 (Weeks 1-12) | |
| Percentage of Participants With ≥50% Reduction From Baseline in MMDs | Baseline up to Week 12 (Weeks 1-12) | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Additional protocol-defined criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama | Hoover | Alabama | 35244-5700 | United States | ||
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| Placebo Comparator |
Participants will receive placebo by intravenous (IV) infusion. |
|
| Group G: Lu AG09222 IV | Experimental | Participants will receive Lu AG09222 by IV infusion. |
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| Group H: Lu AG09222 IV | Experimental | Participants will receive Lu AG09222 by IV infusion. |
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| Group I: Lu AG09222 IV | Experimental | Participants will receive Lu AG09222 by IV infusion. |
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| Placebo | Drug | Placebo matching to Lu AG09222 will be administered per the arm description |
|
| Percentage of Participants With ≥75% Reduction From Baseline in MMDs |
| Baseline up to Week 12 (Weeks 1-12) |
| Change from Baseline in the Number of Monthly Headache Days | Baseline up to Week 12 (Weeks 1-12) |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to Week 20 |
| Number of Participants with Anti-drug Antibodies (ADA) | Up to Week 20 |
| Profound Research - Neurology Center of Southern California |
| Carlsbad |
| California |
| 92011 |
| United States |
| Neurology Center of North Orange County | Fullerton | California | 92835 | United States |
| CenExel CNS | Los Alamitos | California | 90720 | United States |
| ASCLEPES Research Centers | Sherman Oaks | California | 91403 | United States |
| Ki Health Partners LLC DBA New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| K2 Medical Research - Winter Garden | Clermont | Florida | 34711 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| K2 Medical Research, LLC - Maitland | Maitland | Florida | 32751 | United States |
| Aqualane Clinical Research | Naples | Florida | 34105 | United States |
| K2 Medical Research Tampa LLC | Tampa | Florida | 33607 | United States |
| Premiere Research Institute Palm Beach | West Palm Beach | Florida | 33407 | United States |
| Accellacare and McFarland Clinic | Ames | Iowa | 50010 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| Dent Neurosciences Research Center, Inc. | Amherst | New York | 14226 | United States |
| North Suffolk Neurology, PC. | Port Jefferson Station | New York | 11776 | United States |
| Accellacare of Cary - Cary Medical Group | Cary | North Carolina | 27518 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | United States |
| Raleigh Medical Group | Raleigh | North Carolina | 27609 | United States |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | United States |
| Accellacare of Rocky Mount | Rocky Mount | North Carolina | 27804 | United States |
| Triad Neurological Associates | Winston-Salem | North Carolina | 27103 | United States |
| Accellacare of Charleston | Mt. Pleasant | South Carolina | 29464 | United States |
| Internal Medicine and Pediatric Associates of Bristol, PC | Bristol | Tennessee | 37620 | United States |
| Cedar Health Research, LLC | Dallas | Texas | 75251 | United States |
| Mercury Clinical Research | Sugar Land | Texas | 77478 | United States |
| MedStar Health - Neurology Clinic at McLean | McLean | Virginia | 22101 | United States |
| Diagnostic Consultative Center Convex Ltd | Sofia | Sofiiska | 1680 | Bulgaria |
| MC Nevrocentrum | Plovdiv | 4000 | Bulgaria |
| University Multiprofile Hospital for Active Treatment Sveti Georgi | Plovdiv | 4002 | Bulgaria |
| MC Rusemed-OOD | Rousse | 7000 | Bulgaria |
| Neurosanatio s.r.o. | Litomyšl | Pardubice Region | 57001 | Czechia |
| Dr. Radomir Talab MD, Office of | Hradec Králové | 500 03 | Czechia |
| Neuros s.r.o | Pilsen | 30100 | Czechia |
| Clintrial s. r. o. | Prague | 100 00 | Czechia |
| DADO MEDICAL s.r.o. | Prague | 12000 | Czechia |
| Praglandia s.r.o | Prague | 150 00 | Czechia |
| Axon Clinical s r.o | Prague | 15500 | Czechia |
| Neurologicka ordinace FORBELI sro | Prague | 160 00 | Czechia |
| Institut neuropsychiatricke pece | Prague | 18600 | Czechia |
| Neurologicka ambulance | Slezská Ostrava | 710 00 | Czechia |
| NeuroMed Zlin s.r.o. | Zlín | 76001 | Czechia |
| Bispebjerg Hospital - Region Capital | Copenhagen | 2400 | Denmark |
| Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
| Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer | Bron | 69500 | France |
| Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied | Clermont-Ferrand Cedex1 | 63003 | France |
| Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro | Lille | 59037 | France |
| Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone | Marseille | 13385 | France |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere | Paris | 75010 | France |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Pierre-Paul Riquet | Toulouse | 31059 | France |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Tbilisi | 0101 | Georgia |
| Caucasus Medical Center Ltd | Tbilisi | 0102 | Georgia |
| Archangel St Michael Multiprofile Clinical Hospital | Tbilisi | 0159 | Georgia |
| Jo Ann Medical Center | Tbilisi | 0159 | Georgia |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery | Tbilisi | 0159 | Georgia |
| Aversi Clinic | Tbilisi | 0160 | Georgia |
| MD Georgia Staff Physician MediClub Georgia | Tbilisi | 0160 | Georgia |
| S. Khechinashvili University Hospital | Tbilisi | 0179 | Georgia |
| Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) | Berlin | 10117 | Germany |
| Studienzentrum Dr. Bischof GmbH | Böblingen | 71034 | Germany |
| Klinik Haag i. OB | Ebersberg | 85560 | Germany |
| Headache Center Frankfurt | Frankfurt | 65929 | Germany |
| Siteworks - Hannover | Hanover | 30449 | Germany |
| Siteworks - Heidelberg | Heidelberg | 69115 | Germany |
| S-Medicon Kft. | Budapest | Central Hungary (Közép-Magyarország) | 1044 | Hungary |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Jinnouchi Neurosurgery Clinic | Kasuga-shi | Fukuoka | 816-0802 | Japan |
| Ikeda Neurosurgery Clinic | Kasuga-shi | Fukuoka | 816-0824 | Japan |
| Nakamura Memorial Hospital | Sapporo | Hokkaido | 060-0061 | Japan |
| Mito Kyodo General Hospital | Mito | Ibaraki | 310-0015 | Japan |
| Iwate Medical University Uchimaru Medical Center | Morioka | Iwate | 020-8505 | Japan |
| Tanaka Neurosurgery & Headache Clinic | Kagoshima | Kagoshima-ken | 890-0052 | Japan |
| Atsuchi Neurosurgical Hospital | Kagoshima | Kagoshima-ken | 892-0842 | Japan |
| Shonan Keiiku Hospital | Fujisawa-shi | Kanagawa | 252-0816 | Japan |
| Sendai Headache and Neurology Clinic Medical Corporation | Sendai | Miyagi | 982-0014 | Japan |
| Tominaga Hospital | Osaka | Osaka | 556-0017 | Japan |
| Saitama Medical University Hospital | Iruma-gun | Saitama | 350-0495 | Japan |
| Japanese Red Cross Shizuoka Hospital | Shizuoka | Shizuoka | 420-0853 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-Gun | Tochigi | 321-0293 | Japan |
| Shinagawa Strings Clinic | Minato-ku | Tokyo | 108-0075 | Japan |
| Kitasato University Kitasato Institute Hospital | Minato-ku | Tokyo | 108-8642 | Japan |
| Keio University Hospital | Tokyo | 160-8582 | Japan |
| Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | 50161 | Lithuania |
| Klaipeda¿s University Hospital | Klaipėda | LT-92288 | Lithuania |
| Medicum Centrum | Tauragė | 72250 | Lithuania |
| Vilniaus Universiteto Medicinos Fakultetas - Neurologijos ir Neurochirurgijos Klinika - Neurologi... | Vilnius | 08661 | Lithuania |
| Centrum Medyczne HCP sp. z o.o | Poznan | Greater Poland Voivodeship | 61-485 | Poland |
| Landa Specjalistyczne Gabinety Lekarskie | Krakow | Lesser Poland Voivodeship | 31-156 | Poland |
| Centrum Medyczne Neuroprotect | Warsaw | Masovian Voivodeship | 01-684 | Poland |
| Neuro-Care sp. z o.o. sp. Komandytowa | Katowice | Silesian Voivodeship | 40-749 | Poland |
| Centrum Medczyne Pratia Bydgoszcz | Bydgoszcz | 85-796 | Poland |
| Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska | Elblag | 82-300 | Poland |
| Pratia MCM Krakow | Krakow | 30-727 | Poland |
| Centrum Opieki Zdrowotnej OrkanMed | Ksawerów | 95-054 | Poland |
| Appletreeclinics Network Sp. z o.o. | Lodz | 90-347 | Poland |
| Clinirem Sp. z o.o. | Lublin | 20-064 | Poland |
| Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej | Lublin | 20-582 | Poland |
| Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin | 20-701 | Poland |
| Twoja Przychodnia NCM | Nowa Sól | 67-100 | Poland |
| Instytut Zdrowia dr Boczarska-Jedynak | Oświęcim | 32-600 | Poland |
| Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki... | Plewiska | 62-064 | Poland |
| RCMed Oddzial Sochaczew | Sochaczew | 96-500 | Poland |
| MTZ Clinical Research Powered by Pratia | Warsaw | 02-172 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny | Wroclaw | 52-210 | Poland |
| ClinHouse Centrum Medyczne | Zabrze | 41-807 | Poland |
| Sc Clubul Sanatatii S.R.L. | Campulung Muscel | Judet Arges | 115100 | Romania |
| Policlinica CCBR S.R.L. | Bucharest | 30463 | Romania |
| The Emergency County Clinical Hospital St. Andrew Constanta | Constanța | 900591 | Romania |
| Private Practice - Dr. Beáta Dupejová | Banská Bystrica | 974 04 | Slovakia |
| IN MEDIC s.r.o | Bardejov | 085 01 | Slovakia |
| KONZILIUM s.r.o. | Dubnica nad Váhom | 018 41 | Slovakia |
| SANERA, s.r.o. | Prešov | 08001 | Slovakia |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Parc de Salut Mar - Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra | Madrid | 28022 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA) | Valencia | 46010 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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