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

Phase 2
Waitlist Available
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4

Summary

This trial is testing if the drug Lu AG09222 can help people who have not been helped by other migraine prevention medications. Participants will be given either a high dose or low dose. The goal is to see if Lu AG09222 reduces the number of migraine days.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Secondary study objectives
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Percentage of Participants With ≥50% Reduction From Baseline in MMDs

Side effects data

From 2023 Phase 2 trial • 237 Patients • NCT05133323
4%
Fatigue
4%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lu AG09222 Low Dose
Placebo
Lu AG09222 High Dose

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lu AG09222 Low DoseExperimental Treatment1 Intervention
Participants will receive a single low dose of Lu AG09222 by IV infusion.
Group II: Lu AG09222 High DoseExperimental Treatment1 Intervention
Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG09222
2022
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
331 Previous Clinical Trials
77,970 Total Patients Enrolled
15 Trials studying Migraine
4,789 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
190 Previous Clinical Trials
58,452 Total Patients Enrolled
12 Trials studying Migraine
4,039 Patients Enrolled for Migraine
~58 spots leftby Dec 2025
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