A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

NCT06323928 | Completed Phase 2 FDA Drug

• 2 other identifiers: 20297A2023-508821-28-00
• Study Type: interventional
• Target: 874
• Locations: 14 countries
• Sites: 120

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.

Conditions

Migraine

Keywords

Headache; Chronic Migraine; Episodic Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Number of Monthly Migraine Days (MMDs)

  Baseline up to Week 12 (Weeks 1-12)

Secondary Outcomes (6)

• 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)

• 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

Study Arms (9)

Group A: Placebo SC (closed for recruitment)

PLACEBO COMPARATOR

Participants will receive 2 injections of placebo.

Drug: Placebo

Group B: Lu AG09222 SC (closed for recruitment)

EXPERIMENTAL

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Drug: Lu AG09222; Drug: Placebo

Group C: Lu AG09222 SC (closed for recruitment)

EXPERIMENTAL

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Drug: Lu AG09222; Drug: Placebo

Group D: Lu AG09222 SC (closed for recruitment)

EXPERIMENTAL

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Drug: Lu AG09222; Drug: Placebo

Group E: Lu AG09222 SC (closed for recruitment)

EXPERIMENTAL

Participants will receive 2 injections, each containing Lu AG09222.

Drug: Lu AG09222

Group F: Placebo IV

PLACEBO COMPARATOR

Participants will receive placebo by intravenous (IV) infusion.

Drug: Placebo

Group G: Lu AG09222 IV

EXPERIMENTAL

Participants will receive Lu AG09222 by IV infusion.

Drug: Lu AG09222

Group H: Lu AG09222 IV

EXPERIMENTAL

Participants will receive Lu AG09222 by IV infusion.

Drug: Lu AG09222

Group I: Lu AG09222 IV

EXPERIMENTAL

Participants will receive Lu AG09222 by IV infusion.

Drug: Lu AG09222

Interventions

Placebo DRUG

Placebo matching to Lu AG09222 will be administered per the arm description

Group A: Placebo SC (closed for recruitment); Group B: Lu AG09222 SC (closed for recruitment); Group C: Lu AG09222 SC (closed for recruitment); Group D: Lu AG09222 SC (closed for recruitment); Group F: Placebo IV

Lu AG09222 DRUG

Lu AG09222 will be administered per the arm description.

Group B: Lu AG09222 SC (closed for recruitment); Group C: Lu AG09222 SC (closed for recruitment); Group D: Lu AG09222 SC (closed for recruitment); Group E: Lu AG09222 SC (closed for recruitment); Group G: Lu AG09222 IV; Group H: Lu AG09222 IV; Group I: Lu AG09222 IV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (120)

Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama

Hoover, Alabama, 35244-5700, United States

Location

Profound Research - Neurology Center of Southern California

Carlsbad, California, 92011, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

CenExel CNS

Los Alamitos, California, 90720, United States

Location

ASCLEPES Research Centers

Sherman Oaks, California, 91403, United States

Location

Ki Health Partners LLC DBA New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

K2 Medical Research - Winter Garden

Clermont, Florida, 34711, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

K2 Medical Research, LLC - Maitland

Maitland, Florida, 32751, United States

Location

Aqualane Clinical Research

Naples, Florida, 34105, United States

Location

K2 Medical Research Tampa LLC

Tampa, Florida, 33607, United States

Location

Premiere Research Institute Palm Beach

West Palm Beach, Florida, 33407, United States

Location

Accellacare and McFarland Clinic

Ames, Iowa, 50010, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Dent Neurosciences Research Center, Inc.

Amherst, New York, 14226, United States

Location

North Suffolk Neurology, PC.

Port Jefferson Station, New York, 11776, United States

Location

Accellacare of Cary - Cary Medical Group

Cary, North Carolina, 27518, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Raleigh Medical Group

Raleigh, North Carolina, 27609, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Triad Neurological Associates

Winston-Salem, North Carolina, 27103, United States

Location

Accellacare of Charleston

Mt. Pleasant, South Carolina, 29464, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

Cedar Health Research, LLC

Dallas, Texas, 75251, United States

Location

Mercury Clinical Research

Sugar Land, Texas, 77478, United States

Location

MedStar Health - Neurology Clinic at McLean

McLean, Virginia, 22101, United States

Location

Diagnostic Consultative Center Convex Ltd

Sofia, Sofiiska, 1680, Bulgaria

Location

MC Nevrocentrum

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sveti Georgi

Plovdiv, 4002, Bulgaria

Location

MC Rusemed-OOD

Rousse, 7000, Bulgaria

Location

Neurosanatio s.r.o.

Litomyšl, Pardubice Region, 57001, Czechia

Location

Dr. Radomir Talab MD, Office of

Hradec Králové, 500 03, Czechia

Location

Neuros s.r.o

Pilsen, 30100, Czechia

Location

Clintrial s. r. o.

Prague, 100 00, Czechia

Location

DADO MEDICAL s.r.o.

Prague, 12000, Czechia

Location

Praglandia s.r.o

Prague, 150 00, Czechia

Location

Axon Clinical s r.o

Prague, 15500, Czechia

Location

Neurologicka ordinace FORBELI sro

Prague, 160 00, Czechia

Location

Institut neuropsychiatricke pece

Prague, 18600, Czechia

Location

Neurologicka ambulance

Slezská Ostrava, 710 00, Czechia

Location

NeuroMed Zlin s.r.o.

Zlín, 76001, Czechia

Location

Bispebjerg Hospital - Region Capital

Copenhagen, 2400, Denmark

Location

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer

Bron, 69500, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

Clermont-Ferrand Cedex1, 63003, France

Location

Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

Lille, 59037, France

Location

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone

Marseille, 13385, France

Location

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

Paris, 75010, France

Location

Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Pierre-Paul Riquet

Toulouse, 31059, France

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, 0101, Georgia

Location

Caucasus Medical Center Ltd

Tbilisi, 0102, Georgia

Location

Archangel St Michael Multiprofile Clinical Hospital

Tbilisi, 0159, Georgia

Location

Jo Ann Medical Center

Tbilisi, 0159, Georgia

Location

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, 0159, Georgia

Location

Aversi Clinic

Tbilisi, 0160, Georgia

Location

MD Georgia Staff Physician MediClub Georgia

Tbilisi, 0160, Georgia

Location

S. Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

Berlin, 10117, Germany

Location

Studienzentrum Dr. Bischof GmbH

Böblingen, 71034, Germany

Location

Klinik Haag i. OB

Ebersberg, 85560, Germany

Location

Headache Center Frankfurt

Frankfurt, 65929, Germany

Location

Siteworks - Hannover

Hanover, 30449, Germany

Location

Siteworks - Heidelberg

Heidelberg, 69115, Germany

Location

S-Medicon Kft.

Budapest, Central Hungary (Közép-Magyarország), 1044, Hungary

Location

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800, Hungary

Location

Jinnouchi Neurosurgery Clinic

Kasuga-shi, Fukuoka, 816-0802, Japan

Location

Ikeda Neurosurgery Clinic

Kasuga-shi, Fukuoka, 816-0824, Japan

Location

Nakamura Memorial Hospital

Sapporo, Hokkaido, 060-0061, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, 310-0015, Japan

Location

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-8505, Japan

Location

Tanaka Neurosurgery & Headache Clinic

Kagoshima, Kagoshima-ken, 890-0052, Japan

Location

Atsuchi Neurosurgical Hospital

Kagoshima, Kagoshima-ken, 892-0842, Japan

Location

Shonan Keiiku Hospital

Fujisawa-shi, Kanagawa, 252-0816, Japan

Location

Sendai Headache and Neurology Clinic Medical Corporation

Sendai, Miyagi, 982-0014, Japan

Location

Tominaga Hospital

Osaka, Osaka, 556-0017, Japan

Location

Saitama Medical University Hospital

Iruma-gun, Saitama, 350-0495, Japan

Location

Japanese Red Cross Shizuoka Hospital

Shizuoka, Shizuoka, 420-0853, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-Gun, Tochigi, 321-0293, Japan

Location

Shinagawa Strings Clinic

Minato-ku, Tokyo, 108-0075, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Hospital of Lithuanian University of Health Sciences Kaunas

Kaunas, 50161, Lithuania

Location

Klaipeda¿s University Hospital

Klaipėda, LT-92288, Lithuania

Location

Medicum Centrum

Tauragė, 72250, Lithuania

Location

Vilniaus Universiteto Medicinos Fakultetas - Neurologijos ir Neurochirurgijos Klinika - Neurologi...

Vilnius, 08661, Lithuania

Location

Centrum Medyczne HCP sp. z o.o

Poznan, Greater Poland Voivodeship, 61-485, Poland

Location

Landa Specjalistyczne Gabinety Lekarskie

Krakow, Lesser Poland Voivodeship, 31-156, Poland

Location

Centrum Medyczne Neuroprotect

Warsaw, Masovian Voivodeship, 01-684, Poland

Location

Neuro-Care sp. z o.o. sp. Komandytowa

Katowice, Silesian Voivodeship, 40-749, Poland

Location

Centrum Medczyne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

Location

Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska

Elblag, 82-300, Poland

Location

Pratia MCM Krakow

Krakow, 30-727, Poland

Location

Centrum Opieki Zdrowotnej OrkanMed

Ksawerów, 95-054, Poland

Location

Appletreeclinics Network Sp. z o.o.

Lodz, 90-347, Poland

Location

Clinirem Sp. z o.o.

Lublin, 20-064, Poland

Location

Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej

Lublin, 20-582, Poland

Location

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, 20-701, Poland

Location

Twoja Przychodnia NCM

Nowa Sól, 67-100, Poland

Location

Instytut Zdrowia dr Boczarska-Jedynak

Oświęcim, 32-600, Poland

Location

Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki...

Plewiska, 62-064, Poland

Location

RCMed Oddzial Sochaczew

Sochaczew, 96-500, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny

Wroclaw, 52-210, Poland

Location

ClinHouse Centrum Medyczne

Zabrze, 41-807, Poland

Location

Sc Clubul Sanatatii S.R.L.

Campulung Muscel, Judet Arges, 115100, Romania

Location

Policlinica CCBR S.R.L.

Bucharest, 30463, Romania

Location

The Emergency County Clinical Hospital St. Andrew Constanta

Constanța, 900591, Romania

Location

Private Practice - Dr. Beáta Dupejová

Banská Bystrica, 974 04, Slovakia

Location

IN MEDIC s.r.o

Bardejov, 085 01, Slovakia

Location

KONZILIUM s.r.o.

Dubnica nad Váhom, 018 41, Slovakia

Location

SANERA, s.r.o.

Prešov, 08001, Slovakia

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Parc de Salut Mar - Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Clinica Universidad de Navarra

Madrid, 28022, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)

Valencia, 46010, Spain

Location

Hospital Universitario La Fe de Valencia

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2024
• Primary Completion: January 16, 2026
• Study Completion: March 16, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

BU (4); DE (6); FR (6); ES (7); HU (2); US (28); DK (2); JP (16); PL (19); SL (4); RO (3); GE (8); CZ (11); LI (4)