NCT06323928

A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 874 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Conditions

• Migraine

Interventions

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

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-01-16
• Completion: 2026-04-30
• First posted: 2024-03-21
• Last updated: 2026-04-15

Locations

120 sites across 14 countries: United States, Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Japan, Lithuania, Poland, Romania, Slovakia, Spain

Regulatory

• FDA-regulated drug study