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Lu AG09222 for Migraine

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
Awards & highlights

Study Summary

This trial is testing whether a drug called Lu AG09222 can help prevent migraines for people who haven't been helped by other treatments.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Secondary outcome measures
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
325 Previous Clinical Trials
77,346 Total Patients Enrolled
12 Trials studying Migraine
4,549 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,103 Total Patients Enrolled
11 Trials studying Migraine
4,051 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants will be included in this clinical trial?

"That is accurate. The website clinicaltrials.gov has information indicating that this trial, which was posted on November 11th 2021, currently seeking patients. There are plans to enroll 230 individuals at 3 locations across the study."

Answered by AI

How do I sign up to take part in this research?

"ICHD-3 guidelines are being used to confirm that participants aged 18 to 65 years old have migraine in order to be admitted into the study. Furthermore, these potential patients must have a history of migraine lasting at least 12 months and documented evidence of failing 2-4 (maximum) different preventive medications in the last 10 years."

Answered by AI

Does Lu AG09222 have the FDA's okay for use?

"Lu AG09222 falls into Phase 2 of clinical trials. This means that while there is some data supporting safety, there is none yet affirming efficacy."

Answered by AI

Are people with the required qualifications able to enroll in this trial at the present time?

"The trial is still recruiting patients, as seen on clinicaltrials.gov. This particular study was first posted on November 11th 2021 and has since been updated for the last time on November 7th, 2022."

Answered by AI

Does the age limit for this study exclude senior citizens?

"The age restriction for this particular clinical trial is 18-65. There are 32 other trials that patients under the age of 18 can apply to and 122 for patients over 65."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
2021. "A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05133323.
~69 spots leftby Apr 2025
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