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Finding the right dose of Lu-AG09222 for migraine prevention in adults

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

Phase 2 Interventional H. Lundbeck A/S · NCT06323928

This study is testing different doses of a new migraine prevention medication to see if it can help adults who haven't found relief from other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment898 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorH. Lundbeck A/S Industry-sponsored
Locations108 sites (Hoover, Alabama and 107 other locations)
Trial IDNCT06323928 on ClinicalTrials.gov

What this trial studies

This trial aims to identify effective doses of Lu AG09222 for preventing migraines in adults who have not found relief from 1 to 4 prior preventive treatments. Participants will be monitored for their migraine frequency and response to the medication compared to a placebo. The study is designed to determine the optimal dosing strategy to enhance migraine management. It follows a structured approach to assess the safety and efficacy of the treatment in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 with a history of migraines for at least 12 months and who have experienced treatment failure with multiple preventive medications.

Not a fit: Patients who have previously received anti-PACAP treatments or have significant confounding pain syndromes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from chronic migraines who have not responded to existing therapies.

How similar studies have performed: Other studies exploring similar migraine treatments have shown promise, but this specific approach with Lu AG09222 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Hoover, Alabama and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MigraineHeadacheChronic MigraineEpisodic Migraine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.