RecruitingPhase 2NCT06602479

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

Sponsor

AbbVie

Enrollment

488 participants

Start Date

Oct 7, 2024

Study Type

INTERVENTIONAL

Conditions

Migraine

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a new injectable treatment called MEDI0618 to see whether it can reduce the frequency of migraines in adults who get episodic migraines (4 to 14 migraine days per month) and have not responded to at least two previous preventive medications. MEDI0618 is a biologic drug given by injection under the skin, and the study includes people who have not yet tried a CGRP-targeting therapy as well as those who have tried and failed one. Adults aged 18 to 70 with a confirmed history of migraines for at least 12 months and at least 12 migraine headache days in the past 3 months may be eligible. Participation involves a 4-week baseline period to track headaches, followed by receiving injections of MEDI0618 or placebo and attending regular clinic visits for monitoring. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMEDI0618

MEDI0618 per protocol

DRUGPlacebo

Volume-matched placebo for all arms

Locations(54)

Flourish - Birmingham

Birmingham, Alabama, United States

Tennessee Valley Neurological Associates PC

Huntsville, Alabama, United States

The Neurology Center of Southern California - Carlsbad Office

La Jolla, California, United States

Clinical Research Institute, LCC

Los Angeles, California, United States

Homestead Associates in Research, Inc.

Homestead, Florida, United States

Florida Neurology - Lake Mary

Lake Mary, Florida, United States

Flourish Research - Miami, LLC dba Flourish Research

Miami, Florida, United States

BayCare Medical Group Neurology at St. Anthony's Hospital

St. Petersburg, Florida, United States

Santos Research Center, Corp - Tampa

Tampa, Florida, United States

Norton Neuroscience Institute - Headache Clinic

Louisville, Kentucky, United States

Modern Migraine, MD

New York, New York, United States

Velocity Clinical Research, Providence (East Greenwich)

East Greenwich, Rhode Island, United States

Palmetto Primary Care Physicians Division of Gastroenterology - Summerville

Summerville, South Carolina, United States

FutureSearch Trials

Austin, Texas, United States

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, United States

The Mind+ Neurology Clinic

Mequon, Wisconsin, United States

Brain-Soultherapy s.r.o.

Kladno, Czechia

Clintrial s.r.o.

Prague, Czechia

DADO Medical s.r.o.

Prague, Czechia

Axon Clinical s.r.o.

Prague, Czechia

Praglandia s.r.o.

Prague, Czechia

Forbeli s.r.o

Prague, Czechia

Institut Neuropsychiatricke Pece (INEP)

Prague, Czechia

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, Czechia

Rigshospitalet (Copenhagen University Hospital) - Dansk Hovedpinecenter (Danish Headache Center)

Glostrup Municipality, Denmark

Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Neurologie

Berlin, Germany

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Essen

Essen, Germany

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Germany

Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz

Westerstede, Germany

Óbudai Egészségügyi Centrum

Budapest, Hungary

S-Medicon Kft.

Budapest, Hungary

Obudai Egeszsegugyi Centrum - Dunaujvaros

Dunaújváros, Hungary

IRCCS Ospedale San Raffaele

Milan, Italy

IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Pavia, Italy

Policlinico Universitario Campus Bio-Medico

Roma, Italy

IRCCS San Raffaele Pisana

Roma, Italy

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Poland

Centrum Medyczne Pratia - Katowice

Katowice, Poland

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Poland

FutureMeds Sp. z.o.o.

Krakow, Poland

Centrum Medyczne Hope Clinic

Lublin, Poland

Solumed Centrum Medyczne

Poznan, Poland

Centrum Medyczne HCP Sp. z o.o.

Poznan, Poland

FutureMeds Warszawa Centrum

Warsaw, Poland

MTZ Clinical Research Sp. z o.o.

Warsaw, Poland

European Trial Group (ETG) - Warszawa

Warsaw, Poland

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06602479

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