A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Launched by H. LUNDBECK A/S · Mar 15, 2024
Trial Information
Current as of April 30, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called Lu-AG09222 to see if it can help prevent migraines in adults who haven’t found relief from other treatments. If you suffer from migraines and have tried 2 to 4 different medications in the past without success, this trial might be a good fit for you. To qualify, you need to have been diagnosed with migraines for at least a year, have migraine attacks occurring 4 or more days each month, and have started experiencing migraines by the age of 50.
Participants in the trial will be given different doses of Lu-AG09222 to find out which one works best for preventing migraines. Throughout the study, you’ll be monitored closely to see how well the medication is helping and whether there are any side effects. It’s important to know that this trial is open to all adults aged 18 and older, and it’s currently recruiting participants. If you’re interested, this could be an opportunity to try a new treatment option for your migraines.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • 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.
- Key Exclusion Criteria:
- • The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
- • 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.
About H. Lundbeck A/S
H. Lundbeck A/S is a global pharmaceutical company dedicated to improving the quality of life for patients with brain disorders. Founded in 1915 and headquartered in Denmark, Lundbeck specializes in research, development, manufacturing, and marketing of innovative treatments for conditions such as depression, schizophrenia, and Alzheimer's disease. With a strong commitment to neuroscience, Lundbeck invests significantly in clinical trials to advance the understanding and treatment of psychiatric and neurological disorders, aiming to deliver effective solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alicante, , Spain
Raleigh, North Carolina, United States
Glostrup, , Denmark
Tokyo, , Japan
Tbilisi, , Georgia
Fullerton, California, United States
Greensboro, North Carolina, United States
Pamplona, , Spain
Amherst, New York, United States
Shimotsuga Gun, Tochigi, Japan
Bristol, Tennessee, United States
Jacksonville, Florida, United States
Hazelwood, Missouri, United States
Minato Ku, Tokyo, Japan
Elblag, , Poland
Iruma Gun, Saitama, Japan
Bucuresti, , Romania
Tbilisi, , Georgia
Mito, Ibaraki, Japan
Chesterfield, Missouri, United States
Minato Ku, , Japan
Zabrze, , Poland
Stamford, Connecticut, United States
Tbilisi, , Georgia
Sochaczew, , Poland
Praha 8, , Czechia
Raleigh, North Carolina, United States
Kaunas, , Lithuania
Bardejov, , Slovakia
Berlin, , Germany
Madrid, , Spain
Oswiecim, , Poland
Shizuoka Shi, Shizuoka, Japan
Warszawa, Mazowieckie, Poland
Dallas, Texas, United States
Sugar Land, Texas, United States
Minato Ku, Tokyo, Japan
Praha 2, , Czechia
Dubnica Nad Vahom, , Slovakia
Maitland, Florida, United States
Rocky Mount, North Carolina, United States
Mount Pleasant, South Carolina, United States
Kagoshima Shi, Kagoshima, Japan
Naples, Florida, United States
Warszawa, , Poland
Ames, Iowa, United States
Barcelona, , Spain
Lublin, , Poland
Tampa, Florida, United States
Krakow, , Poland
Tatabanya, , Hungary
Nowa Sol, , Poland
Los Alamitos, California, United States
Tbilisi, , Georgia
Cary, North Carolina, United States
Sherman Oaks, California, United States
Clermont, Florida, United States
Carlsbad, California, United States
Hoover, Alabama, United States
West Palm Beach, Florida, United States
Sendai Shi, Miyagi Ken, Japan
Prague, , Czechia
Carlsbad, California, United States
Stamford, Connecticut, United States
Budapest, Central Hungary (Közép Magyarország), Hungary
Kasuga, Fukuoka, Japan
Kagoshima Shi, Kagoshima, Japan
Winston Salem, North Carolina, United States
Sapporo, Hokkaido, Japan
Morioka, Iwate, Japan
Osaka Shi, Osaka Fu, Japan
Krakow, Małopolskie, Poland
Presov, , Slovakia
Mclean, Virginia, United States
Sofia, Sofiiska, Bulgaria
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Plzen, , Czechia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Frankfurt, , Germany
Haag In Oberbayern, , Germany
Hannover, , Germany
Kasuga Shi, Fukuoka Ken, Japan
Fujisawa, , Japan
Minato Ku, , Japan
Shimotsu Gun, , Japan
Taurage, , Lithuania
Katowice, , Poland
Lublin, , Poland
Wroclaw, , Poland
Campulung, , Romania
Constanta, , Romania
Cary, North Carolina, United States
Litomyshl, Pardubicky, Czechia
Praha 5, , Czechia
Praha 6, , Czechia
Slezska Ostrava, , Czechia
Zlin, , Czechia
Kobenhavn, , Denmark
Boeblingen, , Germany
Kasuga Shi, Fukuoka Ken, Japan
Sapporo, Hokkaidâ¿, Japan
Kagoshima Shi, Kagoshima Ken, Japan
Kagoshima Shi, Kagoshima Ken, Japan
Fujisawa Shi, Kanagawa Ken, Japan
Shizuoka Shi, Shizuoka Ken, Japan
Klaipeda, , Lithuania
Katowice, Slaskie, Poland
Bydgoszcz, , Poland
Lodz, , Poland
Lublin, , Poland
Lublin, , Poland
Plewiska, , Poland
Campulung,, Judet Arges, Romania
Hradec Kralove, , Czechia
Poznan, Wielkopolskie, Poland
Ksawerow, , Poland
Prague, , Czechia
Bron, , France
Marseille Cedex 5, , France
Sapporo, Hokkaid¿, Japan
Lublin, , Poland
Clermont, Florida, United States
Mclean, Virginia, United States
Sofia, Sofiiska, Bulgaria
Kagoshima City, Kagoshima, Japan
Valencia, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported