A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
CompletedPhase 2NCT06323928
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: Lu AG09222
- Drug: Placebo
- Sponsor
- H. Lundbeck A/S
- Start date
- 2024-04-01
- Primary completion
- 2026-01-16
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Japan, Lithuania, Poland, Romania, Slovakia, Spain, United States
- Total sites listed
- 120
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06323928