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

Migraine Clinical Trial

— PROCEED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323928
• Other study ID #: 20297A
• Secondary ID: 2023-508821-28-0
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 2 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 498
• Est. completion date: September 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
• The participant has a history of migraine onset = 12 months prior to the Screening Visit.
• The participant has a migraine onset at =50 years of age.
• The participant has =4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.

Key Exclusion Criteria:

• The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
• The participant has confounding and clinically significant pain syndromes.
• The participant has a diagnosis of acute or active temporomandibular disorder.
• The participant has a history or diagnosis of confounding headaches. Additional protocol-defined criteria apply.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Lu AG09222
Lu AG09222 will be administered using subcutaneous (SC) injection.
• Placebo
Placebo matching to Lu AG09222 will be administered by SC injection.

Locations

Country	Name	City	State
United States	Accellacare of Charleston	Mount Pleasant	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Number of Monthly Migraine Days (MMDs)		Baseline up to Week 12 (Weeks 1-12)
Secondary	Change From Baseline in MMDs		Baseline up to Week 12 (Weeks 1-12)
Secondary	Percentage of Participants With =50% Reduction From Baseline in MMDs		Baseline up to Week 12 (Weeks 1-12)
Secondary	Percentage of Participants With =75% Reduction From Baseline in MMDs		Baseline up to Week 12 (Weeks 1-12)
Secondary	Change from Baseline in the Number of Monthly Headache Days		Baseline up to Week 12 (Weeks 1-12)
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Up to Week 20
Secondary	Number of Participants with Anti-drug Antibodies (ADA)		Up to Week 20