NCT06602479

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

A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants With Episodic Migraine

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 488 (estimated)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.

Detailed description

This Phase 2, randomised, multicentre, parallel-group treatment, double-blind, placebo -controlled study is designed to evaluate the safety and efficacy of subcutaneous (SC) MEDI0618 in participants with episodic migraine. The study includes a cohort of participants who have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy (aCGRP-N) but have not yet done so; The study also includes a smaller cohort of participants who have failed one or more aCGRP therapies (aCGRP-IRs) used for preventative treatment and have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	MEDI0618	MEDI0618 per protocol
DRUG	Placebo	Volume-matched placebo for all arms

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-12-18
• Completion: 2027-05-07
• First posted: 2024-09-19
• Last updated: 2026-01-22

Locations

54 sites across 8 countries: United States, Czechia, Denmark, Germany, Hungary, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study