Phase 2 Study of Subcutaneous MEDI0618 Versus Placebo for Reducing Migraine Days in Adults with Episodic Migraine

What this Trial Is About

Researchers are conducting a Phase 2 study to assess the safety and effectiveness of a drug called MEDI0618 compared to a placebo in adults with episodic migraine. The study includes participants who have not responded to at least two different small molecule migraine preventive treatments and are either eligible but have not used aCGRP therapies or have previously failed one or more aCGRP preventive treatments. This research aims to improve migraine prevention options for these individuals. Participants will receive subcutaneous injections of MEDI0618 or placebo in a double-blind, randomized design. The study has multiple dosing arms including Dose A and three additional doses for the group not previously treated with aCGRP therapies, with participants assigned in a 11 ratio to either active drug or placebo. A separate group who have failed aCGRP therapies will also be randomized 11 to receive MEDI0618 or placebo. The treatment period includes repeated dosing and evaluation of the drugs impact on migraine occurrence. Throughout the study, participants will be monitored for migraine headache days and the severity and disability caused by migraines from baseline through treatment. Evaluations will occur regularly from Day 1 to Day 141, including assessments focusing on migraine frequency between Weeks 9 and 12. Safety and efficacy will be closely observed in a controlled setting, and the study is expected to conclude in May 2027.

A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine