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Purpose

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 2 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Group A: Placebo 		Participants will receive 2 injections of placebo.
  • Drug: Placebo
    Placebo matching to Lu AG09222 will be administered by SC injection.
Experimental
Group B: Lu AG09222 		Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
  • Drug: Lu AG09222
    Lu AG09222 will be administered using subcutaneous (SC) injection.
  • Drug: Placebo
    Placebo matching to Lu AG09222 will be administered by SC injection.
Experimental
Group C: Lu AG09222 		Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
  • Drug: Lu AG09222
    Lu AG09222 will be administered using subcutaneous (SC) injection.
  • Drug: Placebo
    Placebo matching to Lu AG09222 will be administered by SC injection.
Experimental
Group D: Lu AG09222 		Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
  • Drug: Lu AG09222
    Lu AG09222 will be administered using subcutaneous (SC) injection.
  • Drug: Placebo
    Placebo matching to Lu AG09222 will be administered by SC injection.
Experimental
Group E: Lu AG09222 		Participants will receive 2 injections, each containing Lu AG09222.
  • Drug: Lu AG09222
    Lu AG09222 will be administered using subcutaneous (SC) injection.

Recruiting Locations

MedStar Health - Primary Care and Pediatrics
McLean, Virginia 22101

More Details

Status
Recruiting
Sponsor
H. Lundbeck A/S

Study Contact

Email contact via H. Lundbeck A/S
+45 36301311
LundbeckClinicalTrials@Lundbeck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.