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

Description

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.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Hoover

Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama, Hoover, Alabama, United States, 35244-5700

Carlsbad

Profound Research - Neurology Center of Southern California, Carlsbad, California, United States, 92011

Fullerton

Neurology Center of North Orange County, Fullerton, California, United States, 92835

Los Alamitos

CenExel CNS, Los Alamitos, California, United States, 90720

Sherman Oaks

Asclepes Research Centers, Sherman Oaks, California, United States, 91403

Stamford

New England Institute for Clinical Research (NEICR) - Stamford, Stamford, Connecticut, United States, 06905

Clermont

K2 Medical Research - Winter Garden, Clermont, Florida, United States, 34711

Jacksonville

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida, United States, 32256

Maitland

K2 Medical Research, LLC, Maitland, Florida, United States, 32751

Naples

Aqualane Clinical Research, Naples, Florida, United States, 34105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lundbeck A/S,

Study Record Dates

2025-09-30