Skip to main content
OpenTrials
Completed

NCT Number: NCT05133323

A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines.

People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them.

When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CCR Ostrava s.r.o., Ostrava, Moravian-Silesian Region, Czechia

Loading trial locations.

About this study

Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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 at least 12 months prior to the Screening Visit.
  • The participant has a migraine onset at ≤50 years of age.
  • The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.

Key Exclusion Criteria:

  • The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
  • 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.

Treatment and study plan

Lu AG09222

Drug

Lu AG09222 will be administered per schedule specified in the arm.

Placebo

Drug

Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

Primary outcomes

  1. Change From Baseline in the Number of Monthly Migraine Days (MMDs)

    Time frame: Baseline, Week 4

    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

    • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
    • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
    • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
    • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication

Secondary outcomes

  1. Percentage of Participants With ≥50% Reduction From Baseline in MMDs

    Time frame: Baseline, Week 4

    The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

    • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
    • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
    • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
    • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication

  2. Change From Baseline in the Number of Monthly Headache Days (MHDs)

    Time frame: Baseline, Week 4

    A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 24, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.