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

JRCT ID: jRCT2031240164

Registered date:14/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 14/06/2024
• Target sample size: 135
• Countries of recruitment: US,Japan,Bulgaria,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Georgia,Japan,Germany,Japan,Hungary,Japan,Lithuania,Japan,Poland,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): Lu AG09222 or placebo matching to Lu AG09222 will be administered by SC injection.

Outcome(s)

• Primary Outcome: Change From Baseline in the Number of Monthly Migraine Days (MMDs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yazawa Masanari
• Secondary ID(s): NCT06323928