Clinical trial NCT06323928: A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Migraine
Keywords: Headache
Chronic Migraine
Episodic Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 898
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs)
timeFrame: Baseline up to Week 12 (Weeks 1-12)
Secondary outcomes:
measure: Change From Baseline in MMDs
timeFrame: Baseline up to Week 12 (Weeks 1-12)
measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs
timeFrame: Baseline up to Week 12 (Weeks 1-12)
measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs
timeFrame: Baseline up to Week 12 (Weeks 1-12)
measure: Change from Baseline in the Number of Monthly Headache Days
timeFrame: Baseline up to Week 12 (Weeks 1-12)
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 20
measure: Number of Participants with Anti-drug Antibodies (ADA)
timeFrame: Up to Week 20
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
state: Alabama
city: Carlsbad
country: United States
facility: Profound Research - Neurology Center of Southern California
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Los Alamitos
country: United States
facility: CenExel CNS
state: California
city: Sherman Oaks
country: United States
facility: Asclepes Research Centers
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research (NEICR) - Stamford
state: Connecticut
city: Clermont
country: United States
facility: K2 Medical Research - Winter Garden
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, LLC
state: Florida
city: Naples
country: United States
facility: Aqualane Clinical Research
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research Tampa LLC
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute Palm Beach
state: Florida
city: Ames
country: United States
facility: Accellacare and McFarland Clinic
state: Iowa
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc.
state: New York
city: Commack
country: United States
facility: North Suffolk Neurology, PC.
state: New York
city: Cary
country: United States
facility: Accellacare of Cary - Cary Medical Group
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Medical Group
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare of Rocky Mount
state: North Carolina
city: Winston-Salem
country: United States
facility: Triad Neurological Associates
state: North Carolina
city: Mount Pleasant
country: United States
facility: Accellacare of Charleston
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol, PC
state: Tennessee
city: Dallas
country: United States
facility: Cedar Health Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Mercury Clinical Research
state: Texas
city: McLean
country: United States
facility: MedStar Health - Neurology Clinic at McLean
state: Virginia
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Convex Ltd
state: Sofiiska
city: Plovdiv
country: Bulgaria
facility: MC Nevrocentrum
city: Ruse
country: Bulgaria
facility: MC Rusemed-OOD
city: Litomyshl
country: Czechia
facility: Neurosanatio s.r.o.
state: Pardubicky
city: Hradec Kralove
country: Czechia
facility: Dr. Radomir Talab MD, Office of
city: Plzen
country: Czechia
facility: Neuros s.r.o
city: Prague
country: Czechia
facility: Clintrial s. r. o.
city: Praha 2
country: Czechia
facility: DADO MEDICAL s.r.o.
city: Praha 5
country: Czechia
facility: Axon Clinical s r.o
city: Praha 6
country: Czechia
facility: Neurologicka ordinace FORBELI sro
city: Praha 8
country: Czechia
facility: Institut neuropsychiatricke pece
city: Slezska Ostrava
country: Czechia
facility: Neurologicka ambulance
city: Zlin
country: Czechia
facility: NeuroMed Zlin s.r.o.
city: Glostrup
country: Denmark
facility: Glostrup Hospital
city: Kobenhavn
country: Denmark
facility: Bispebjerg Hospital - Region Capital
city: Bron
country: France
facility: Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer
city: Marseille Cedex 5
country: France
facility: Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
city: Tbilisi
country: Georgia
facility: American Hospital Network
city: Tbilisi
country: Georgia
facility: Archangel St Michael Multiprofile Clinical Hospital
city: Tbilisi
country: Georgia
facility: Jo Ann Medical Center
city: Tbilisi
country: Georgia
facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: Aversi Clinic
city: Tbilisi
country: Georgia
facility: MD Georgia Staff Physician MediClub Georgia
city: Tbilisi
country: Georgia
facility: S. Khechinashvili University Hospital
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
city: Boeblingen
country: Germany
facility: Studienzentrum Dr. Bischof GmbH
city: Frankfurt
country: Germany
facility: Headache Center Frankfurt
city: Haag in Oberbayern
country: Germany
facility: Klinik Haag i. OB
city: Hannover
country: Germany
facility: Siteworks - Hannover
city: Budapest
country: Hungary
facility: S-Medicon Kft.
state: Central Hungary (Közép-Magyarország)
city: Tatabanya
country: Hungary
facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgery Clinic
state: Fukuoka-Ken
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgery Clinic
state: Fukuoka-Ken
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaid¿
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital-Cancer Center
state: Iwate
city: Kagoshima-shi
country: Japan
facility: Atsuchi Neurosurgical Hospital
state: Kagoshima-Ken
city: Kagoshima-city
country: Japan
facility: Tanaka Neurosurgery & Headache Clinic
state: Kagoshima
city: Fujisawa-shi
country: Japan
facility: Shonan Keiiku Hospital
state: Kanagawa-ken
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation
state: Miyagi-Ken
city: Osaka-shi
country: Japan
facility: Tominaga Hospital
state: Osaka-Fu
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
state: Shizuoka-Ken
city: Shimotsuga-Gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Minato-ku
country: Japan
facility: Shinagawa Strings Clinic
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas
city: Klaipeda
country: Lithuania
facility: PI University Hospital of Klaipeda
city: Taurage
country: Lithuania
facility: Medicum Centrum
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Krakow
country: Poland
facility: Landa Specjalistyczne Gabinety Lekarskie
state: Małopolskie
city: Katowice
country: Poland
facility: Neuro-Care
state: Slaskie
city: Poznan
country: Poland
facility: Centrum Medyczne HCP sp. z o.o
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: Centrum Medczyne Pratia Bydgoszcz
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
city: Krakow
country: Poland
facility: Pratia MCM Krakow
city: Ksawerow
country: Poland
facility: Centrum Opieki Zdrowotnej OrkanMed
city: Lodz
country: Poland
facility: Appletreeclinics Network Sp. z o.o.
city: Lublin
country: Poland
facility: Clinirem Sp. z o.o.
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej
city: Lublin
country: Poland
facility: Centrum Medyczne Hope Clinic Sebastian Szklener
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia NCM
city: Oswiecim
country: Poland
facility: Instytut Zdrowia dr Boczarska-Jedynak
city: Plewiska
country: Poland
facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki...
city: Sochaczew
country: Poland
facility: RCMed Oddzial Sochaczew
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny
city: Zabrze
country: Poland
facility: ClinHouse Centrum Medyczne
city: Campulung,
country: Romania
facility: Sc Clubul Sanatatii S.R.L.
state: Judet Arges
city: Bucuresti
country: Romania
facility: Policlinica CCBR S.R.L.
city: Constanta
country: Romania
facility: The Emergency County Clinical Hospital St. Andrew Constanta
city: Bardejov
country: Slovakia
facility: IN MEDIC s.r.o
city: Dubnica nad Vahom
country: Slovakia
facility: KONZILIUM s.r.o.
city: Presov
country: Slovakia
facility: SANERA, s.r.o.
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)
Study officials:
References: