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A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

NCT06323928

CompletedPhase 2

Sponsor: H. Lundbeck A/S

Conditions: Migraine

Interventions: Lu AG09222, Placebo

Countries: United States, Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (120)
  • Hoover, Alabama, United States
  • Carlsbad, California, United States
  • Fullerton, California, United States
  • Los Alamitos, California, United States
  • Sherman Oaks, California, United States
  • Stamford, Connecticut, United States
  • Clermont, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Naples, Florida, United States
  • Tampa, Florida, United States
  • West Palm Beach, Florida, United States
  • Ames, Iowa, United States
  • Chesterfield, Missouri, United States
  • Hazelwood, Missouri, United States
  • Amherst, New York, United States
  • Port Jefferson Station, New York, United States
  • Cary, North Carolina, United States
  • Greensboro, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Raleigh, North Carolina, United States
  • Rocky Mount, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Mt. Pleasant, South Carolina, United States
  • Bristol, Tennessee, United States
  • Dallas, Texas, United States
  • Sugar Land, Texas, United States
  • McLean, Virginia, United States
  • Sofia, Sofiiska, Bulgaria
  • Plovdiv, Bulgaria
  • + 90 more on CT.gov