Interventional, randomized, double-blind, parallel-group, placebo-controlled study of Lu AG09222 for the prevention of migraine in patients with unsuccessful prior preventive treatments

H. Lundbeck A/S0 个研究点目标入组 230 人开始时间: 2021年8月3日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•- 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 at least 12 months prior to the Screening Visit.
•- The participant has a migraine onset of =50 years of age.
•- The participant has =8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
•- The participant fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
•- Migraine occurring on =8 days and headache occurring on =26 days.
•- The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 230
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
•- 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.

发起方