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OpenTrials
Completed

NCT Number: NCT06323928

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Diagnostic Consultative Center Convex Ltd, Sofia, Sofiiska, Bulgaria

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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 ≥ 12 months prior to the Screening Visit.
  • 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 3 months prior to the Screening Visit.
  • The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.

Key Exclusion Criteria:

  • The participant has previously been dosed with an anti-pituitary adenylate cyclase-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.

Treatment and study plan

Lu AG09222

Drug

Lu AG09222 will be administered per the arm description.

Placebo

Drug

Placebo matching to Lu AG09222 will be administered per the arm description

Primary outcomes

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

    Time frame: Baseline up to Week 12 (Weeks 1-12)

Secondary outcomes

  1. Change From Baseline in MMDs

    Time frame: Baseline up to Week 12 (Weeks 1-12)

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

    Time frame: Baseline up to Week 12 (Weeks 1-12)

  3. Percentage of Participants With ≥75% Reduction From Baseline in MMDs

    Time frame: Baseline up to Week 12 (Weeks 1-12)

  4. Change from Baseline in the Number of Monthly Headache Days

    Time frame: Baseline up to Week 12 (Weeks 1-12)

  5. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Week 20

  6. Number of Participants with Anti-drug Antibodies (ADA)

    Time frame: Up to Week 20

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

Acronym: PROCEED

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Jun 12, 2026

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.

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