Clinical trial NCT05133323: A Study 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 Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-11-24
Enrollment: 237
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: Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines.

People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them.

When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

Detailed description: Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.

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 at least 12 months prior to the Screening Visit.
* The participant has a migraine onset at ≤50 years of age.
* The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.

Key Exclusion Criteria:

* The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
* 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.

Primary outcomes:
measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs)
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs
timeFrame: Baseline, Week 4
measure: Change From Baseline in the Number of Monthly Headache Days (MHDs)
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Excell Research - ClinEdge - PPDS
state: California
city: Sherman Oaks
country: United States
facility: UNISON Clinical Trials (Shahram Jacobs md inc.)
state: California
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
state: Jihomoravsky Kraj
city: Ostrava
country: Czechia
facility: CCR Ostrava s.r.o.
state: Moravskoslezsky Kraj
city: Ostrava
country: Czechia
facility: Mestska nemocnice Ostrava, p.o.
state: Moravskoslezsky Kraj
city: Pardubice
country: Czechia
facility: CCR Czech
state: Pardubicky Kraj
city: Praha
country: Czechia
facility: CCR Prague s.r.o.
state: Praha, Hlavní Mesto
city: Chocen
country: Czechia
facility: NEUROHK, s.r.o.
city: Prague
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha 6
country: Czechia
facility: FORBELI s.r.o.
city: Praha 8
country: Czechia
facility: INEP Medical s.r.o.
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup-Nordre Ringvej 57
state: Capital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
state: Central Jutland
city: Tbilisi
country: Georgia
facility: Ltd Israel-Georgia Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: Archangel St Michael Multiprofile Clinical Hospital Ltd
city: Tbilisi
country: Georgia
facility: Aversi Clinic LTD
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
city: Tbilisi
country: Georgia
facility: Ltd Multiprofile Clinic "Consilium Medulla"
city: Krakow
country: Poland
facility: Pratia MCM
state: Malopolskie
city: Oswiecim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak
state: Malopolskie
city: Warszawa
country: Poland
facility: ETG Singua - PPDS
state: Mazowieckie
city: Katowice
country: Poland
facility: Centrum Medyczne Silmedic Sp z o o
state: Slaskie
city: Poznan
country: Poland
facility: Solumed SC
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
city: Banska Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
city: Dubnica nad Vahom
country: Slovakia
facility: KONZILIUM s.r.o
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: