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

Last updated: June 11, 2026
Sponsor: H. Lundbeck A/S
Overall Status: Completed

Phase

2

Condition

Chronic Pain

Oral Facial Pain

Migraine (Adult)

Treatment

Placebo

Lu AG09222

Clinical Study ID

NCT06323928
20297A
2023-508821-28-00
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The participant has a diagnosis of migraine as defined by InternationalClassification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed atthe Screening Visit.

  • The participant has a history of migraine onset ≥ 12 months prior to the ScreeningVisit.

  • The participant has a migraine onset at ≤50 years of age.

  • The participant has ≥4 migraine days per month for each month within the past 3months prior to the Screening Visit.

  • The participant has documented evidence of treatment failure in the past 10 years ofat least 1 to 4 (maximum) different migraine preventive medications.

Exclusion

Key Exclusion Criteria:

  • The participant has previously been dosed with an anti-pituitary adenylatecyclase-activating peptide (anti-PACAP treatment).

  • 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.

Additional protocol-defined criteria apply.

Study Design

Total Participants: 874
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 01, 2024
Estimated Completion Date:
March 16, 2026

Connect with a study center

  • Diagnostic Consultative Center Convex Ltd

    Sofia, Sofiiska 1680
    Bulgaria

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  • Second Multiprofile Hospital for Active Treatment (SMHAT)

    Sofia, Sofiiska 1680
    Bulgaria

    Active - Recruiting

  • MC Nevrocentrum

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveti Georgi

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveti Georgi

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • MC Rusemed-OOD

    Rousse, 7000
    Bulgaria

    Site Not Available

  • Neurosanatio s.r.o.

    Litomyšl, Pardubice Region 57001
    Czechia

    Site Not Available

  • Dr. Radomir Talab MD, Office of

    Hradec Králové, 500 03
    Czechia

    Site Not Available

  • Neuros s.r.o

    Pilsen, 30100
    Czechia

    Site Not Available

  • Axon Clinical s r.o

    Prague, 15500
    Czechia

    Site Not Available

  • CLINTRIAL s.r.o.

    Prague, 100 00
    Czechia

    Active - Recruiting

  • Clintrial s. r. o.

    Prague, 100 00
    Czechia

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  • DADO MEDICAL s.r.o.

    Prague, 12000
    Czechia

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  • Institut neuropsychiatricke pece

    Prague, 18600
    Czechia

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  • Neurologicka ordinace FORBELI sro

    Prague, 160 00
    Czechia

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    Prague, 150 00
    Czechia

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    Prague 3067696, 100 00
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    Prague 3067696, 12000
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    Prague 3067696, 18600
    Czechia

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    Prague 3067696, 160 00
    Czechia

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    Copenhagen, 2400
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    Bron, 69500
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    Clermont-Ferrand Cedex1, 63003
    France

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    Lille, 59037
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    Toulouse, 31059
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    Tbilisi, 0102
    Georgia

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    Osaka, Osaka 556-0017
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    Valencia, 46026
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    Fullerton, California 92835
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    Tampa, Florida 33607
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    West Palm Beach, Florida 33407
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    Ames, Iowa 50010
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    Chesterfield, Missouri 63005
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    Amherst, New York 14226
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