A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
Start Date
10/7/2024
Completion Date
5/7/2027
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.
Eligibility Criteria
Age Range: 18 years to 70 years
Interventions
MEDI0618
Placebo
Conditions
Locations
Flourish - Birmingham
Birmingham, Alabama 35205
United States
Tennessee Valley Neurological Associates PC
Huntsville, Alabama 35801
United States
The Neurology Center of Southern California - Carlsbad Office
La Jolla, California 92037
United States
Clinical Research Institute, LCC
Los Angeles, California 90048
United States
Homestead Associates in Research, Inc.
Homestead, Florida 33033
United States
Florida Neurology - Lake Mary
Lake Mary, Florida 32746
United States
Flourish Research - Miami, LLC dba Flourish Research
Miami, Florida 33135
United States
BayCare Medical Group Neurology at St. Anthony's Hospital
St. Petersburg, Florida 33705
United States
Santos Research Center, Corp - Tampa
Tampa, Florida 33615
United States
Norton Neuroscience Institute - Headache Clinic
Louisville, Kentucky 40207
United States
Modern Migraine, MD
New York, New York 10001
United States
Velocity Clinical Research, Providence (East Greenwich)
East Greenwich, Rhode Island 02818
United States
Palmetto Primary Care Physicians Division of Gastroenterology - Summerville
Summerville, South Carolina 29486
United States
FutureSearch Trials
Austin, Texas 78731
United States
Vaught Neurological Services, PLLC
Crab Orchard, West Virginia 25827
United States
The Mind+ Neurology Clinic
Mequon, Wisconsin 53092
United States
Brain-Soultherapy s.r.o.
Kladno, 272 01
Czechia
Clintrial s.r.o.
Prague, 100 00
Czechia
DADO Medical s.r.o.
Prague, 120 00
Czechia
Axon Clinical s.r.o.
Prague, 150 00
Czechia
Praglandia s.r.o.
Prague, 150 00
Czechia
Forbeli s.r.o
Prague, 160 00
Czechia
Institut Neuropsychiatricke Pece (INEP)
Prague, 186 00
Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 266 55
Czechia
Rigshospitalet (Copenhagen University Hospital) - Dansk Hovedpinecenter (Danish Headache Center)
Glostrup Municipality, 2600
Denmark
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Neurologie
Berlin, 10117
Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, 09111
Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitätsklinikum Essen
Essen, 45147
Germany
Kopfschmerzzentrum Frankfurt
Frankfurt am Main, 65929
Germany
Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz
Westerstede, 26655
Germany
Óbudai Egészségügyi Centrum
Budapest, 1036
Hungary
S-Medicon Kft.
Budapest, 1138
Hungary
Obudai Egeszsegugyi Centrum - Dunaujvaros
Dunaújváros, 2400
Hungary
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, 27100
Italy
Policlinico Universitario Campus Bio-Medico
Roma, 00128
Italy
IRCCS San Raffaele Pisana
Roma, 00163
Italy
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796
Poland
Centrum Medyczne Pratia - Katowice
Katowice, 40-081
Poland
Specjalistyczne Gabinety Sp. z o.o.
Krakow, 30-539
Poland
FutureMeds Sp. z.o.o.
Krakow, 31-501
Poland
Centrum Medyczne Hope Clinic
Lublin, 20-701
Poland
Solumed Centrum Medyczne
Poznan, 60-529
Poland
Centrum Medyczne HCP Sp. z o.o.
Poznan, 61-485
Poland
FutureMeds Warszawa Centrum
Warsaw, 00-215
Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, 02-172
Poland
European Trial Group (ETG) - Warszawa
Warsaw, 02-677
Poland
Hospital Universitario de Badajoz
Badajoz, 06080
Spain
Hospital del Mar
Barcelona, 08003
Spain
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Barcelona, 08035
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Spain