Migraine
Conditions
Keywords
Headache, Chronic Migraine, Episodic Migraine
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.
Interventions
DRUGLu AG09222
Lu AG09222 will be administered per the arm description.
DRUGPlacebo
Placebo matching to Lu AG09222 will be administered per the arm description
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in the Number of Monthly Migraine Days (MMDs) | Baseline up to Week 12 (Weeks 1-12) |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants with Anti-drug Antibodies (ADA) | Up to Week 20 |
Countries
Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Japan, Lithuania, Poland, Romania, Slovakia, Spain, United States
Contacts
STUDY_DIRECTOREmail contact via H. Lundbeck A/S
H. Lundbeck A/S
Outcome results
None listed