A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
NCT ID: NCT06323928
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
874 participants
INTERVENTIONAL
2024-04-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group A: Placebo SC (closed for recruitment)
Participants will receive 2 injections of placebo.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Group B: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Group C: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Group D: Lu AG09222 SC (closed for recruitment)
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Group E: Lu AG09222 SC (closed for recruitment)
Participants will receive 2 injections, each containing Lu AG09222.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Group F: Placebo IV
Participants will receive placebo by intravenous (IV) infusion.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Group G: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Group H: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Group I: Lu AG09222 IV
Participants will receive Lu AG09222 by IV infusion.
Lu AG09222
Lu AG09222 will be administered per the arm description.
Interventions
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Lu AG09222
Lu AG09222 will be administered per the arm description.
Placebo
Placebo matching to Lu AG09222 will be administered per the arm description
Eligibility Criteria
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Inclusion Criteria
* The participant has a history of migraine onset ≥ 12 months prior to the Screening Visit.
* The participant has a migraine onset at ≤50 years of age.
* The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.
Exclusion Criteria
* The participant has confounding and clinically significant pain syndromes.
* The participant has a diagnosis of acute or active temporomandibular disorder.
* The participant has a history or diagnosis of confounding headaches.
Additional protocol-defined criteria apply.
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Locations
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Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
Hoover, Alabama, United States
Profound Research - Neurology Center of Southern California
Carlsbad, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
CenExel CNS
Los Alamitos, California, United States
ASCLEPES Research Centers
Sherman Oaks, California, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
K2 Medical Research - Winter Garden
Clermont, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
K2 Medical Research, LLC - Maitland
Maitland, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
K2 Medical Research Tampa LLC
Tampa, Florida, United States
Premiere Research Institute Palm Beach
West Palm Beach, Florida, United States
Accellacare and McFarland Clinic
Ames, Iowa, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
North Suffolk Neurology, PC.
Port Jefferson Station, New York, United States
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, United States
Headache Wellness Center
Greensboro, North Carolina, United States
Raleigh Medical Group
Raleigh, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, United States
Triad Neurological Associates
Winston-Salem, North Carolina, United States
Accellacare of Charleston
Mt. Pleasant, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
Cedar Health Research, LLC
Dallas, Texas, United States
Mercury Clinical Research
Sugar Land, Texas, United States
MedStar Health - Neurology Clinic at McLean
McLean, Virginia, United States
Diagnostic Consultative Center Convex Ltd
Sofia, Sofiiska, Bulgaria
MC Nevrocentrum
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi
Plovdiv, , Bulgaria
MC Rusemed-OOD
Rousse, , Bulgaria
Neurosanatio s.r.o.
Litomyšl, Pardubický kraj, Czechia
Dr. Radomir Talab MD, Office of
Hradec Králové, , Czechia
Neuros s.r.o
Pilsen, , Czechia
Clintrial s. r. o.
Prague, , Czechia
DADO MEDICAL s.r.o.
Prague, , Czechia
Praglandia s.r.o
Prague, , Czechia
Axon Clinical s r.o
Prague, , Czechia
Neurologicka ordinace FORBELI sro
Prague, , Czechia
Institut neuropsychiatricke pece
Prague, , Czechia
Neurologicka ambulance
Slezská Ostrava, , Czechia
NeuroMed Zlin s.r.o.
Zlín, , Czechia
Bispebjerg Hospital - Region Capital
Copenhagen, , Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer
Bron, , France
Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
Clermont-Ferrand Cedex1, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille, , France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone
Marseille, , France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris, , France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Pierre-Paul Riquet
Toulouse, , France
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, , Georgia
Caucasus Medical Center Ltd
Tbilisi, , Georgia
Archangel St Michael Multiprofile Clinical Hospital
Tbilisi, , Georgia
Jo Ann Medical Center
Tbilisi, , Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, , Georgia
Aversi Clinic
Tbilisi, , Georgia
MD Georgia Staff Physician MediClub Georgia
Tbilisi, , Georgia
S. Khechinashvili University Hospital
Tbilisi, , Georgia
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin, , Germany
Studienzentrum Dr. Bischof GmbH
Böblingen, , Germany
Headache Center Frankfurt
Frankfurt, , Germany
Klinik Haag i. OB
Haag in Oberbayern, , Germany
Siteworks - Hannover
Hanover, , Germany
Siteworks - Heidelberg
Heidelberg, , Germany
S-Medicon Kft.
Budapest, Central Hungary (Közép-Magyarország), Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Tatabánya, , Hungary
Jinnouchi Neurosurgery Clinic
Kasuga-shi, Fukuoka, Japan
Ikeda Neurosurgery Clinic
Kasuga-shi, Fukuoka, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaid¿, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, Japan
Atsuchi Neurosurgical Hospital
Kagoshima, Kagoshima-ken, Japan
Shonan Keiiku Hospital
Fujisawa-shi, Kanagawa, Japan
Sendai Headache and Neurology Clinic Medical Corporation
Sendai, Miyagi, Japan
Tominaga Hospital
Osaka, Osaka, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, Japan
Shinagawa Strings Clinic
Minato-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan
Keio University Hospital
Tokyo, , Japan
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , Lithuania
Klaipeda¿s University Hospital
Klaipėda, , Lithuania
Medicum Centrum
Tauragė, , Lithuania
Vilniaus Universiteto Medicinos Fakultetas - Neurologijos ir Neurochirurgijos Klinika - Neurologi...
Vilnius, , Lithuania
Centrum Medyczne HCP sp. z o.o
Poznan, Greater Poland Voivodeship, Poland
Landa Specjalistyczne Gabinety Lekarskie
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Neuroprotect
Warsaw, Masovian Voivodeship, Poland
Neuro-Care sp. z o.o. sp. Komandytowa
Katowice, Silesian Voivodeship, Poland
Centrum Medczyne Pratia Bydgoszcz
Bydgoszcz, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
Elblag, , Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Opieki Zdrowotnej OrkanMed
Ksawerów, , Poland
Appletreeclinics Network Sp. z o.o.
Lodz, , Poland
Clinirem Sp. z o.o.
Lublin, , Poland
Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej
Lublin, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, , Poland
Twoja Przychodnia NCM
Nowa Sól, , Poland
Instytut Zdrowia dr Boczarska-Jedynak
Oświęcim, , Poland
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki...
Plewiska, , Poland
RCMed Oddzial Sochaczew
Sochaczew, , Poland
MTZ Clinical Research Powered by Pratia
Warsaw, , Poland
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, , Poland
ClinHouse Centrum Medyczne
Zabrze, , Poland
Sc Clubul Sanatatii S.R.L.
Campulung Muscel, Judet Arges, Romania
Policlinica CCBR S.R.L.
Bucharest, , Romania
The Emergency County Clinical Hospital St. Andrew Constanta
Constanța, , Romania
Private Practice - Dr. Beáta Dupejová
Banská Bystrica, , Slovakia
IN MEDIC s.r.o
Bardejov, , Slovakia
KONZILIUM s.r.o.
Dubnica nad Váhom, , Slovakia
SANERA, s.r.o.
Prešov, , Slovakia
Hospital General Universitario de Alicante
Alicante, , Spain
Parc de Salut Mar - Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
Valencia, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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20297A
Identifier Type: -
Identifier Source: org_study_id
2023-508821-28-00
Identifier Type: OTHER
Identifier Source: secondary_id