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Calcitonin Gene-Related Peptide (CGRP) Antagonist

Lu AG09222 for Migraine (PROCEED Trial)

Phase 2
Recruiting
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 up to week 12 (weeks 1-12)
Awards & highlights

Summary

This trial aims to find the right doses of Lu AG09222 to prevent migraines in people who have tried other medications without success.

Who is the study for?
This trial is for adults who have suffered from migraines for over a year, get them at least 4 days each month, and haven't found relief with 2-4 other preventive medications. They must have been diagnosed according to specific guidelines and had their first migraine before turning 51.Check my eligibility
What is being tested?
The study is testing different doses of a new medication called Lu AG09222 against a placebo to see which dose might prevent migraines in people who didn't respond well to previous treatments. Participants will be randomly assigned to receive either the drug or placebo.See study design
What are the potential side effects?
While the side effects of Lu AG09222 are not detailed here, common side effects in trials like this may include reactions at the injection site, nausea, fatigue, and possibly others depending on how individuals react to the medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 12 (weeks 1-12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 12 (weeks 1-12) 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 MMDs
Change from Baseline in the Number of Monthly Headache Days
Number of Participants with Anti-drug Antibodies (ADA)
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Group E: Lu AG09222Experimental Treatment1 Intervention
Participants will receive 2 injections, each containing Lu AG09222.
Group II: Group D: Lu AG09222Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group III: Group C: Lu AG09222Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group IV: Group B: Lu AG09222Experimental Treatment2 Interventions
Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group V: Group A: PlaceboPlacebo Group1 Intervention
Participants will receive 2 injections of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Lu AG09222
2022
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
327 Previous Clinical Trials
77,203 Total Patients Enrolled
13 Trials studying Migraine
4,390 Patients Enrolled for Migraine
~332 spots leftby Jul 2025