RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-04-01
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06323928

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * The participant has a history of migraine onset ≥ 12 months prior to the Screening Visit.
  3. * The participant has a migraine onset at ≤50 years of age.
  4. * The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  5. * The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.
  1. * The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
  2. * The participant has confounding and clinically significant pain syndromes.
  3. * The participant has a diagnosis of acute or active temporomandibular disorder.
  4. * The participant has a history or diagnosis of confounding headaches.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
Hoover, Alabama, 35244-5700
United States
Profound Research - Neurology Center of Southern California
Carlsbad, California, 92011
United States
Neurology Center of North Orange County
Fullerton, California, 92835
United States
CenExel CNS
Los Alamitos, California, 90720
United States
Asclepes Research Centers
Sherman Oaks, California, 91403
United States
New England Institute for Clinical Research (NEICR) - Stamford
Stamford, Connecticut, 06905
United States
K2 Medical Research - Winter Garden
Clermont, Florida, 34711
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
United States
K2 Medical Research, LLC
Maitland, Florida, 32751
United States
Aqualane Clinical Research
Naples, Florida, 34105
United States
K2 Medical Research Tampa
Tampa, Florida, 33607
United States
Premiere Research Institute Palm Beach
West Palm Beach, Florida, 33407
United States
Accellacare and McFarland Clinic
Ames, Iowa, 50010
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
Healthcare Research Network
Hazelwood, Missouri, 63042
United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226
United States
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, 27518
United States
Headache Wellness Center
Greensboro, North Carolina, 27405
United States
Raleigh Medical Group
Raleigh, North Carolina, 27609
United States
M3 Wake Research, Inc
Raleigh, North Carolina, 27612
United States
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804
United States
Triad Neurological Associates
Winston-Salem, North Carolina, 27103
United States
Accellacare of Charleston
Mount Pleasant, South Carolina, 29464
United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
United States
Cedar Health Research, LLC
Dallas, Texas, 75251
United States
Mercury Clinical Research
Sugar Land, Texas, 77478
United States
MedStar Health - Neurology Clinic at McLean
McLean, Virginia, 22101
United States

Collaborators and Investigators

Sponsor: H. Lundbeck A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Headache
  • Chronic Migraine
  • Episodic Migraine

Additional Relevant MeSH Terms

  • Migraine