A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
- Registration Number
- NCT06323928
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 898
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Placebo SC (closed for recruitment) Placebo Participants will receive 2 injections of placebo. Group B: Lu AG09222 SC (closed for recruitment) Lu AG09222 Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group B: Lu AG09222 SC (closed for recruitment) Placebo Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group C: Lu AG09222 SC (closed for recruitment) Lu AG09222 Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group C: Lu AG09222 SC (closed for recruitment) Placebo Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group D: Lu AG09222 SC (closed for recruitment) Lu AG09222 Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group D: Lu AG09222 SC (closed for recruitment) Placebo Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222. Group E: Lu AG09222 SC (closed for recruitment) Lu AG09222 Participants will receive 2 injections, each containing Lu AG09222. Group F: Placebo IV Placebo Participants will receive placebo by intravenous (IV) infusion. Group G: Lu AG09222 IV Lu AG09222 Participants will receive Lu AG09222 by IV infusion. Group H: Lu AG09222 IV Lu AG09222 Participants will receive Lu AG09222 by IV infusion. Group I: Lu AG09222 IV Lu AG09222 Participants will receive Lu AG09222 by IV infusion.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Number of Monthly Migraine Days (MMDs) Baseline up to Week 12 (Weeks 1-12)
- Secondary Outcome Measures
Name Time Method 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 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)
Trial Locations
- Locations (107)
Axon Clinical s r.o
🇨🇿Praha 5, Czechia
Neurologicka ordinace FORBELI sro
🇨🇿Praha 6, Czechia
Institut neuropsychiatricke pece
🇨🇿Praha 8, Czechia
Neurologicka ambulance
🇨🇿Slezska Ostrava, Czechia
NeuroMed Zlin s.r.o.
🇨🇿Zlin, Czechia
American Hospital Network
🇬🇪Tbilisi, Georgia
K2 Medical Research Tampa LLC
🇺🇸Tampa, Florida, United States
Clintrial s. r. o.
🇨🇿Prague, Czechia
ClinHouse Centrum Medyczne
🇵🇱Zabrze, Poland
DADO MEDICAL s.r.o.
🇨🇿Praha 2, Czechia
Dr. Radomir Talab MD, Office of
🇨🇿Hradec Kralove, Czechia
Neuros s.r.o
🇨🇿Plzen, Czechia
Hospital of Lithuanian University of Health Sciences Kaunas
🇱🇹Kaunas, Lithuania
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
New England Institute for Clinical Research (NEICR) - Stamford
🇺🇸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, Florida, United States
Aqualane Clinical Research
🇺🇸Naples, 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
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
🇺🇸Mount 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
MC Rusemed-OOD
🇧🇬Ruse, Bulgaria
Neurosanatio s.r.o.
🇨🇿Litomyshl, Pardubicky, Czechia
Glostrup Hospital
🇩🇰Glostrup, Denmark
Bispebjerg Hospital - Region Capital
🇩🇰Kobenhavn, Denmark
Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer
🇫🇷Bron, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone
🇫🇷Marseille Cedex 5, France
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
🇬🇪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
🇩🇪Boeblingen, Germany
Headache Center Frankfurt
🇩🇪Frankfurt, Germany
Klinik Haag i. OB
🇩🇪Haag in Oberbayern, Germany
Siteworks - Hannover
🇩🇪Hannover, Germany
S-Medicon Kft.
🇭🇺Budapest, Central Hungary (Közép-Magyarország), Hungary
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
🇭🇺Tatabanya, Hungary
Jinnouchi Neurosurgery Clinic
🇯🇵Kasuga-shi, Fukuoka-Ken, Japan
Ikeda Neurosurgery Clinic
🇯🇵Kasuga-shi, Fukuoka-Ken, Japan
Nakamura Memorial Hospital
🇯🇵Sapporo, Hokkaid¿, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan
Iwate Medical University Hospital-Cancer Center
🇯🇵Morioka, Iwate, Japan
Atsuchi Neurosurgical Hospital
🇯🇵Kagoshima-shi, Kagoshima-Ken, Japan
Tanaka Neurosurgery & Headache Clinic
🇯🇵Kagoshima-city, Kagoshima, Japan
Shonan Keiiku Hospital
🇯🇵Fujisawa-shi, Kanagawa-ken, Japan
Sendai Headache and Neurology Clinic Medical Corporation
🇯🇵Sendai-shi, Miyagi-Ken, Japan
Tominaga Hospital
🇯🇵Osaka-shi, Osaka-Fu, Japan
Saitama Medical University Hospital
🇯🇵Iruma-gun, Saitama, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka-shi, Shizuoka-Ken, 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
PI University Hospital of Klaipeda
🇱🇹Klaipeda, Lithuania
Medicum Centrum
🇱🇹Taurage, Lithuania
Centrum Medyczne NeuroProtect
🇵🇱Warszawa, Mazowieckie, Poland
Landa Specjalistyczne Gabinety Lekarskie
🇵🇱Krakow, Małopolskie, Poland
Neuro-Care
🇵🇱Katowice, Slaskie, Poland
Centrum Medyczne HCP sp. z o.o
🇵🇱Poznan, Wielkopolskie, 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
🇵🇱Ksawerow, 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 Sol, Poland
Instytut Zdrowia dr Boczarska-Jedynak
🇵🇱Oswiecim, 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
🇵🇱Warszawa, Poland
MIGRE Polskie Centrum Leczenia Migreny
🇵🇱Wroclaw, Poland
Sc Clubul Sanatatii S.R.L.
🇷🇴Campulung,, Judet Arges, Romania
Policlinica CCBR S.R.L.
🇷🇴Bucuresti, Romania
The Emergency County Clinical Hospital St. Andrew Constanta
🇷🇴Constanta, Romania
IN MEDIC s.r.o
🇸🇰Bardejov, Slovakia
KONZILIUM s.r.o.
🇸🇰Dubnica nad Vahom, Slovakia
SANERA, s.r.o.
🇸🇰Presov, Slovakia
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Parc de Salut Mar - Hospital del Mar
🇪🇸Barcelona, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
🇪🇸Valencia, Spain