Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06602479

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

Led by AbbVie · Updated on 2026-01-22

488

Participants Needed

54

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • Weight at least 40 kg and BMI at least 18.0 kg/m2
  • History of migraine headaches with or without aura, starting at age 50 or younger, lasting at least 12 months
  • At least 12 migraine headache days in the 3 months before screening
  • Between 4 and 14 migraine headache days per month during 4 weeks of baseline data collection
  • On at least 4 days, migraine headache must meet specific criteria including migraine without aura or with aura, probable migraine, or respond to migraine-specific medication
  • Participants with medication overuse headache (MOH) are eligible
  • History of unsuccessful treatment with at least 2 small molecule migraine preventive treatments from different classes
  • For participants eligible for aCGRP therapy but who have not yet received it
  • For participants who have tried and failed at least one aCGRP therapy for prevention
  • Ability to distinguish migraine headaches from tension-type headaches
  • Female participants must not be pregnant, lactating, or planning pregnancy during the study, or be of nonchildbearing potential
  • Female participants of childbearing potential who are sexually active with a non-sterilized male partner must use two highly effective contraception methods during the study and 10 weeks after last dose
  • Female participants of childbearing potential must agree to follow safe administration guidelines and avoid egg donation and in vitro fertilization during and after the study
Not Eligible

You will not qualify if you...

  • History of specific migraine types: hemiplegic, ophthalmoplegic, or basilar-type migraine
  • Headache other than migraine within 3 months before screening
  • Severe or ongoing allergy or hypersensitivity reactions, or history of hypersensitivity to immunisations or immunoglobulins
  • Significant psychiatric disorders that could impact safety or data
  • Clinically significant illnesses like cardiovascular, neurologic (except allowed headaches), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine diseases
  • History of cancer within 5 years before screening except certain skin, cervical, or prostate cancers
  • Known drug or alcohol abuse within 1 year before screening or positive drug/alcohol test at screening
  • History of prolonged QT interval or congenital QT syndrome
  • History of symptomatic or treated arrhythmias, except controlled atrial fibrillation
  • Use of migraine preventive medications within 30 days or 5 half-lives prior to screening and during study
  • Prior use of aCGRP therapy for acute or preventive treatment (for aCGRP-N participants)
  • Use of opioids or barbiturate analgesics more than twice a month in last 6 months, except emergency use
  • Use of botulinum toxin injections in head, face, or neck within 4 months before screening
  • Use of migraine treatment devices or interventions within 2 months before screening
  • Use of prescription or non-prescription non-biologic drugs within 7 days or 5 half-lives before screening unless stable and safe
  • Need for another biological therapeutic agent during study
  • Recent participation in other clinical studies with investigational products or devices
  • Known hypersensitivity to MEDI0618 or its ingredients
  • Other protocol-specific inclusion and exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 54 locations

1

Flourish - Birmingham

Birmingham, Alabama, United States, 35205

Actively Recruiting

2

Tennessee Valley Neurological Associates PC

Huntsville, Alabama, United States, 35801

Withdrawn

3

The Neurology Center of Southern California - Carlsbad Office

La Jolla, California, United States, 92037

Actively Recruiting

4

Clinical Research Institute, LCC

Los Angeles, California, United States, 90048

Actively Recruiting

5

Homestead Associates in Research, Inc.

Homestead, Florida, United States, 33033

Not Yet Recruiting

6

Florida Neurology - Lake Mary

Lake Mary, Florida, United States, 32746

Not Yet Recruiting

7

Flourish Research - Miami, LLC dba Flourish Research

Miami, Florida, United States, 33135

Actively Recruiting

8

BayCare Medical Group Neurology at St. Anthony's Hospital

St. Petersburg, Florida, United States, 33705

Not Yet Recruiting

9

Santos Research Center, Corp - Tampa

Tampa, Florida, United States, 33615

Actively Recruiting

10

Norton Neuroscience Institute - Headache Clinic

Louisville, Kentucky, United States, 40207

Withdrawn

11

Modern Migraine, MD

New York, New York, United States, 10001

Withdrawn

12

Velocity Clinical Research, Providence (East Greenwich)

East Greenwich, Rhode Island, United States, 02818

Not Yet Recruiting

13

Palmetto Primary Care Physicians Division of Gastroenterology - Summerville

Summerville, South Carolina, United States, 29486

Actively Recruiting

14

FutureSearch Trials

Austin, Texas, United States, 78731

Actively Recruiting

15

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, United States, 25827

Not Yet Recruiting

16

The Mind+ Neurology Clinic

Mequon, Wisconsin, United States, 53092

Actively Recruiting

17

Brain-Soultherapy s.r.o.

Kladno, Czechia, 272 01

Not Yet Recruiting

18

Clintrial s.r.o.

Prague, Czechia, 100 00

Not Yet Recruiting

19

DADO Medical s.r.o.

Prague, Czechia, 120 00

Not Yet Recruiting

20

Axon Clinical s.r.o.

Prague, Czechia, 150 00

Not Yet Recruiting

21

Praglandia s.r.o.

Prague, Czechia, 150 00

Not Yet Recruiting

22

Forbeli s.r.o

Prague, Czechia, 160 00

Not Yet Recruiting

23

Institut Neuropsychiatricke Pece (INEP)

Prague, Czechia, 186 00

Not Yet Recruiting

24

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, Czechia, 266 55

Not Yet Recruiting

25

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

Glostrup Municipality, Denmark, 2600

Not Yet Recruiting

26

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

Berlin, Germany, 10117

Not Yet Recruiting

27

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, Germany, 09111

Not Yet Recruiting

28

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Not Yet Recruiting

29

Universitätsklinikum Essen

Essen, Germany, 45147

Not Yet Recruiting

30

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Germany, 65929

Not Yet Recruiting

31

Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz

Westerstede, Germany, 26655

Not Yet Recruiting

32

Óbudai Egészségügyi Centrum

Budapest, Hungary, 1036

Not Yet Recruiting

33

S-Medicon Kft.

Budapest, Hungary, 1138

Not Yet Recruiting

34

Obudai Egeszsegugyi Centrum - Dunaujvaros

Dunaújváros, Hungary, 2400

Not Yet Recruiting

35

IRCCS Ospedale San Raffaele

Milan, Italy, 20132

Not Yet Recruiting

36

IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Pavia, Italy, 27100

Not Yet Recruiting

37

Policlinico Universitario Campus Bio-Medico

Roma, Italy, 00128

Not Yet Recruiting

38

IRCCS San Raffaele Pisana

Roma, Italy, 00163

Not Yet Recruiting

39

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Poland, 85-796

Not Yet Recruiting

40

Centrum Medyczne Pratia - Katowice

Katowice, Poland, 40-081

Not Yet Recruiting

41

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Poland, 30-539

Not Yet Recruiting

42

FutureMeds Sp. z.o.o.

Krakow, Poland, 31-501

Not Yet Recruiting

43

Centrum Medyczne Hope Clinic

Lublin, Poland, 20-701

Not Yet Recruiting

44

Solumed Centrum Medyczne

Poznan, Poland, 60-529

Not Yet Recruiting

45

Centrum Medyczne HCP Sp. z o.o.

Poznan, Poland, 61-485

Not Yet Recruiting

46

FutureMeds Warszawa Centrum

Warsaw, Poland, 00-215

Not Yet Recruiting

47

MTZ Clinical Research Sp. z o.o.

Warsaw, Poland, 02-172

Not Yet Recruiting

48

European Trial Group (ETG) - Warszawa

Warsaw, Poland, 02-677

Actively Recruiting

49

Hospital Universitario de Badajoz

Badajoz, Spain, 06080

Not Yet Recruiting

50

Hospital del Mar

Barcelona, Spain, 08003

Not Yet Recruiting

51

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

Barcelona, Spain, 08035

Not Yet Recruiting

52

Hospital Universitario La Paz

Madrid, Spain, 28046

Not Yet Recruiting

53

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Not Yet Recruiting

54

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Not Yet Recruiting

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Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

7

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