NCT06323928CompletedPhase 2
A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 874 (actual)
- First submitted
- 15 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 16 Jan 2026
- Lead sponsor
- H. Lundbeck A/S
- Diseases
- Migraine
- NCT number
- NCT06323928
- EU CT number
- 2023-508821-28-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 874
- From 1 Apr 2024 to the primary completion date, 16 Jan 2026
- 129 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
Other illness
- The participant has confounding and clinically significant pain syndromes.
- The participant has a diagnosis of acute or active temporomandibular disorder.
Other
- The participant has a history or diagnosis of confounding headaches.
- Additional protocol-defined criteria apply.
Who the study is looking for
- The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (129)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Center Nevrocentrum EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Completed |
| Medical Center Rusemed EOOD Coordinator of this site? Confirm its status | Ruse | Bulgaria | Completed |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Diagnostic And Consultative Center Neoclinic EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Neurologie Rs Centrum s.r.o. Coordinator of this site? Confirm its status | Hradec Kralove | Czechia | Completed |
| Neurosanatio s.r.o. Coordinator of this site? Confirm its status | Litomysl-Mesto | Czechia | Completed |
| Neuros s.r.o. Coordinator of this site? Confirm its status | Plzen 3 | Czechia | Completed |
| DADO MEDICAL s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Praglandia s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| INEP medical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| FORBELI s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Clintrial s.r.o. Coordinator of this site? Confirm its status | Prague 10 | Czechia | Completed |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague 5 | Czechia | Completed |
| MP-neuro s.r.o. Coordinator of this site? Confirm its status | Slezká Ostrava | Czechia | Completed |
| NeuroMed Zlin s.r.o. Coordinator of this site? Confirm its status | Zlín | Czechia | Completed |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Studienzentrum Dr. Bischof GmbH Coordinator of this site? Confirm its status | Boeblingen | Germany | Completed |
| Kopfschmerzzentrum Frankfurt Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| curiositas ad sanum Studien und Beratungs GmbH Coordinator of this site? Confirm its status | Haag I.ob | Germany | Completed |
| Siteworks GmbH Coordinator of this site? Confirm its status | Hanover | Germany | Completed |
| Siteworks GmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Jo Ann Medical Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| S.Khechinashvili University Hospital Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Caucasus Medical Center Ltd Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| MD Georgia Staff Physician MediClub Georgia Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Aversi Clinic Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| JSC K. Eristavi National Center of Experimental and Clinical Surgery Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Archangel St Michael Multiprofile Clinical Hospital Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| S-Medicon Kft. Coordinator of this site? Confirm its status | Budapest IV | Hungary | Completed |
| Shonan Keiiku Hospital Coordinator of this site? Confirm its status | Fujisawa-shi | Japan | Unknown status |
| Saitama Medical University Hospital Coordinator of this site? Confirm its status | Iruma-gun | Japan | Unknown status |
| Tanaka Neurosurgery & Headache Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Atsuchi Neurosurgical Hospital Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Jinnouchi Neurosurgery Clinic Coordinator of this site? Confirm its status | Kasuga-shi | Japan | Unknown status |
| Ikeda Neurosurgery Clinic Coordinator of this site? Confirm its status | Kasuga-shi | Japan | Unknown status |
| Kitasato University Kitasato Institute Hospital Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Shinagawa strings clinic Coordinator of this site? Confirm its status | Minato-Ku | Japan | Unknown status |
| Mito Kyodo General Hospital Coordinator of this site? Confirm its status | Mito | Japan | Unknown status |
| Iwate Medical University Uchimaru Medical Center Coordinator of this site? Confirm its status | Morioka | Japan | Unknown status |
| Tominaga Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Nakamura Memorial Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Headache and Neurology Clinic, Medical Corporation Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Unknown status |
| Japanese Red Cross Shizuoka Hospital Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Keio University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Completed |
| Klaipedos universiteto ligonine VšĮ Coordinator of this site? Confirm its status | Klaipeda | Lithuania | Completed |
| Medicum Centrum UAB Coordinator of this site? Confirm its status | Taurage | Lithuania | Completed |
| Vilniaus universiteto ligonine Santaros klinikos VšĮ Coordinator of this site? Confirm its status | Vilnius | Lithuania | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Coordinator of this site? Confirm its status | Elblag | Poland | Completed |
| Neuro-Care Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Specjalistyczne Gabinety Lekarskie Landa Coordinator of this site? Confirm its status | Kraków | Poland | Completed |
| Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j. Coordinator of this site? Confirm its status | Ksawerów | Poland | Completed |
| Appletreeclinics Network Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Medyczne Hope Clinic Sebastian Szklener Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Completed |
| Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki Hertmanowskiej Coordinator of this site? Confirm its status | Plewiska | Poland | Completed |
| Centrum Medyczne HCP Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| RCMed Oddzial Sochaczew Coordinator of this site? Confirm its status | Sochaczew | Poland | Completed |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wrocław | Poland | Completed |
| Clinhouse Sp. z o.o. Coordinator of this site? Confirm its status | Zabrze | Poland | Completed |
| Fizio Center S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Policlinica CCBR S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Clubul Sanatatii S.R.L. Coordinator of this site? Confirm its status | Campulung | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Coordinator of this site? Confirm its status | Constanța | Romania | Completed |
| MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o. Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Completed |
| IN MEDIC, s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Completed |
| Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Coordinator of this site? Confirm its status | Liptovský Mikuláš | Slovakia | Completed |
| Konzilium s.r.o. Coordinator of this site? Confirm its status | Nova Dubnica | Slovakia | Completed |
| SANERA, s.r.o. Coordinator of this site? Confirm its status | Prešov | Slovakia | Completed |
| Univerzitna nemocnica Nemocnica svaeteho Michala a.s. Coordinator of this site? Confirm its status | Stare Mesto | Slovakia | Completed |
| Accellacare and McFarland Clinic Coordinator of this site? Confirm its status | Ames | United States | Unknown status |
| Dent Neurosciences Research Center, Inc Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| Internal Medicine and Pediatric Associates of Bristol, PC Coordinator of this site? Confirm its status | Bristol | United States | Unknown status |
| Profound Research - Neurology Center of Southern California Coordinator of this site? Confirm its status | Carlsbad | United States | Unknown status |
| Accellacare of Cary - Cary Medical Group Coordinator of this site? Confirm its status | Cary | United States | Unknown status |
| Clinical Research Professionals Coordinator of this site? Confirm its status | Chesterfield | United States | Unknown status |
| K2 Medical Research WINTER GARDEN Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Cedar Health Research, LLC Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Neurology Center of North Orange County Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Headache Wellness Center Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Healthcare Research Network Coordinator of this site? Confirm its status | Hazelwood | United States | Unknown status |
| Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama Coordinator of this site? Confirm its status | Hoover | United States | Unknown status |
| Clinical NeuroScience Solutions Inc Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| CenExel CNS Coordinator of this site? Confirm its status | Los Alamitos | United States | Unknown status |
| K2 Medical Research, LLC - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| MedStar Health - Neurology Clinic at McLean Coordinator of this site? Confirm its status | McLean | United States | Unknown status |
| Accellacare of Charleston Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| North Suffolk Neurology, PC Coordinator of this site? Confirm its status | Port Jefferson Station | United States | Unknown status |
| M3 Wake Research, Inc. Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Raleigh Medical Group Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Accellacare of Rocky Mount Coordinator of this site? Confirm its status | Rocky Mount | United States | Unknown status |
| ASCLEPES Research Centers Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| Mercury Clinical Research Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
| K2 Medical Research Tampa LLC Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Premiere Research Institute Palm Beach Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Triad Neurological Associates Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.