NCT05133323

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

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Lu AG09222	Lu AG09222 will be administered per schedule specified in the arm.
DRUG	Placebo	Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

Timeline

• Start date: 2021-11-11
• Primary completion: 2023-01-19
• Completion: 2023-03-16
• First posted: 2021-11-24
• Last updated: 2024-03-13
• Results posted: 2024-02-08

Locations

28 sites across 6 countries: United States, Czechia, Denmark, Georgia, Poland, Slovakia

Regulatory

• FDA-regulated drug study