A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

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.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

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.

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

A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Orlando

Clinical Neuroscience Solutions, Orlando, Florida, United States, 32801

Atlanta

NeuroTrials Research, Atlanta, Georgia, United States, 30328

Austin

Future Search Trials, Austin, Texas, United States, 78731

Seabrook

Elevate Clinical Research, Seabrook, Texas, United States, 77586

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

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,

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

Study Record Dates

2025-07-30