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

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
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031240164
Enrollment
135
Registered
2024-06-14
Start date
2025-04-02
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

Lu AG09222 or placebo matching to Lu AG09222 will be administered by SC injection.

Sponsors

Yazawa Masanari
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 more than or equal to 12 months prior to the Screening Visit. -The participant has a migraine onset at less than or equal to 50 years of age. -The participant has more than or equal to 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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Change From Baseline in the Number of Monthly Migraine Days (MMDs)

Countries

Bulgaria, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Japan, Lithuania, Poland, Romania, Slovakia, Spain, US

Contacts

Public ContactClinical trial contact

ICON Clinical Research GK

Japan-Chiken@iconplc.com+81-6-4560-2001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026