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

Last updated: February 13, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Pain

Oral Facial Pain

Migraine (Adult)

Treatment

Lu AG09222

Placebo

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 2 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: 498
Treatment Group(s): 2
Primary Treatment: Lu AG09222
Phase: 2
Study Start date:
April 01, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

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  • MC Rusemed-OOD

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    Litomyshl, Pardubicky 57001
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    Prague, 100 00
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    Prague, 100 00
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  • DADO MEDICAL s.r.o.

    Praha 2, 12000
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  • Axon Clinical s r.o

    Praha 5, 15500
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  • Neurologicka ordinace FORBELI sro

    Praha 6, 160 00
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    Praha 8, 18600
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    Zlin, 76001
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    Bron, 69500
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    Marseille Cedex 5, 13385
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    Barcelona, 08003
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    Stamford, Connecticut 06905
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    United States

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    United States

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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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    Hazelwood, Missouri 63042
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  • Dent Neurosciences Research Center, Inc.

    Amherst, New York 14226
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  • Accellacare of Cary

    Cary, North Carolina 27518
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  • Accellacare of Cary - Cary Medical Group

    Cary, North Carolina 27518
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  • Headache Wellness Center

    Greensboro, North Carolina 27405
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    Raleigh, North Carolina 27612
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    Raleigh, North Carolina 27609
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    Rocky Mount, North Carolina 27804
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  • Triad Neurological Associates

    Winston-Salem, North Carolina 27103
    United States

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  • Accellacare of Charleston

    Mount Pleasant, South Carolina 29464
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  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee 37620
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  • Cedar Health Research, LLC

    Dallas, Texas 75251
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    Sugar Land, Texas 77478
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  • MedStar Health - Primary Care and Pediatrics

    McLean, Virginia 22101
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