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

Summary

Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

Timeline

Start

2021-11-11

Primary completion

2023-01-19

Completion

2023-03-16

Outcome

Met primary endpoint

registry analysis (superiority test); Lu AG09222 High Dose vs Placebo; p = 0.0106; Mean Difference (Final Values) -2.0; ANCOVA NCT05133323 ↗

paper a single intravenous infusion of 750 mg of Lu AG09222 showed superiority over placebo in reducing migraine frequency over the subsequent 4 weeks. PMID 39231342 ↗

Publications

• Ashina M, Phul R, Khodaie M, Lof E, Florea I. A Monoclonal Antibody to PACAP for Migraine Prevention. N Engl J Med. 2024 Sep 5;391(9):800-809. doi: 10.1056/NEJMoa2314577.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lu AG09222	Monoclonal antibody	100 mg	Intravenous
Subject	Lu AG09222	Monoclonal antibody	750 mg	Intravenous

Indications