Phase 2
Completed N=237
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Source: ClinicalTrials.gov NCT05133323 ↗Enrolled (actual)
237
Serious AEs
0.4%
Results posted
Feb 2024
Primary outcomePrimary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) — -6.2; -6.0; -4.2 days — p=0.0106
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Monthly Migraine Days (MMDs) |
-6.2; -6.0; -4.2 | 0.0106 sig |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in MMDs |
32.2; 36.1; 26.8 | — |
| SECONDARY Change From Baseline in the Number of Monthly Headache Days (MHDs) |
-5.8; -5.9; -4.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05133323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.