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

March 12, 2024 updated by: H. Lundbeck A/S

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Chocen, Czechia, 565 01
        • NEUROHK, s.r.o.
      • Prague, Czechia
        • CLINTRIAL s.r.o.
      • Praha 6, Czechia, 160 00
        • FORBELI s.r.o.
      • Praha 8, Czechia, 186 00
        • INEP Medical s.r.o.
    • Jihomoravsky Kraj
      • Brno, Jihomoravsky Kraj, Czechia, 656 91
        • Fakultni nemocnice u sv. Anny v Brne
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 702 00
        • CCR Ostrava s.r.o.
      • Ostrava, Moravskoslezsky Kraj, Czechia, 728 80
        • Mestska nemocnice Ostrava, p.o.
    • Pardubicky Kraj
      • Pardubice, Pardubicky Kraj, Czechia, 530 02
        • CCR Czech
    • Praha, Hlavní Mesto
      • Praha, Praha, Hlavní Mesto, Czechia, 130 00
        • CCR Prague s.r.o.
  • Denmark
    • Capital
      • Glostrup, Capital, Denmark, 2600
        • Rigshospitalet Glostrup-Nordre Ringvej 57
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Aarhus Universitetshospital
  • Georgia
      • Tbilisi, Georgia, 0112
        • Ltd Israel-Georgia Medical Research Clinic Helsicore
      • Tbilisi, Georgia, 0159
        • Archangel St Michael Multiprofile Clinical Hospital Ltd
      • Tbilisi, Georgia, 0160
        • Aversi Clinic Ltd
      • Tbilisi, Georgia, 0160
        • LTD MediClubGeorgia
      • Tbilisi, Georgia, 0172
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
      • Tbilisi, Georgia, 0186
        • Ltd Multiprofile Clinic "Consilium Medulla"
  • Poland
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
        • Pratia MCM
      • Oswiecim, Malopolskie, Poland, 32-600
        • Instytut Zdrowia dr Boczarska-Jedynak
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-777
        • ETG Singua - PPDS
    • Slaskie
      • Katowice, Slaskie, Poland, 40-282
        • Centrum Medyczne Silmedic Sp z o o
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-101
        • Solumed SC
  • Slovakia
      • Banska Bystrica, Slovakia, 974 04
        • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
      • Dubnica nad Vahom, Slovakia, 018 41
        • KONZILIUM s.r.o
  • United States
    • California
      • Oceanside, California, United States, 92056-4515
        • Excell Research - ClinEdge - PPDS
      • Sherman Oaks, California, United States, 91403
        • UNISON Clinical Trials (Shahram Jacobs md inc.)
    • Florida
      • Miami, Florida, United States, 33155-4630
        • Allied Biomedical Research Institute

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lu AG09222 High Dose
Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
Drug: Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm.
Experimental: Lu AG09222 Low Dose
Participants will receive a single low dose of Lu AG09222 by IV infusion.
Drug: Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm.
Placebo Comparator: Placebo
Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
Drug: Placebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Week 4
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.
Baseline, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, 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 Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

March 16, 2023

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19678A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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