COMPLETED

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

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Conditions

Migraine

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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 main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.

Official Title

Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine

Quick Facts

Study Start:2024-09-13
Study Completion:2025-07-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06578585

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 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 ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the Screening Visit.
  4. * The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit.
  1. * The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment.
  2. * The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
  3. * The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives of that product, whichever is longer, prior to Visit 1.
  4. * The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
  5. * The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients.

Contacts and Locations

Principal Investigator

Email contact via H. Lundbeck A/S
STUDY_DIRECTOR
H. Lundbeck A/S

Study Locations (Sites)

Clinical Neuroscience Solutions
Orlando, Florida, 32801
United States
NeuroTrials Research
Atlanta, Georgia, 30328
United States
Future Search Trials
Austin, Texas, 78731
United States
Elevate Clinical Research
Seabrook, Texas, 77586
United States

Collaborators and Investigators

Sponsor: H. Lundbeck A/S

  • Email contact via H. Lundbeck A/S, STUDY_DIRECTOR, 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 Date2024-09-13
Study Completion Date2025-07-11

Study Record Updates

Study Start Date2024-09-13
Study Completion Date2025-07-11

Terms related to this study

Additional Relevant MeSH Terms

  • Migraine