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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 up to 5 years

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.
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.
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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
329 Previous Clinical Trials
77,199 Total Patients Enrolled
14 Trials studying Migraine
4,378 Patients Enrolled for Migraine
~266 spots leftby Jul 2025
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