Actively Recruiting
A Phase 2, Randomised, Multicentre, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous MEDI0618 Compared to Placebo in Adults With Episodic Migraine
Led by AbbVie · Updated on 2026-05-19
488
Participants Needed
54
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
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 1:1 ratio to either active drug or placebo. A separate group who have failed aCGRP therapies will also be randomized 1:1 to receive MEDI0618 or placebo. The treatment period includes repeated dosing and evaluation of the drug's 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.
CONDITIONS
Brief Title
A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
Who Can Participate
Eligibility Criteria
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 and lasting at least 12 months prior to screening
- At least 12 migraine headache days in the last 3 months before screening
- During 4 weeks before Day 1, between 4 and 14 migraine headache days per month, including at least 4 days meeting migraine criteria or responding to migraine-specific medication
- Participants with medication overuse headache are eligible
- History of unsuccessful treatment with at least 2 small molecule migraine preventives from different classes
- For aCGRP-Naive group: eligible for but not previously treated with aCGRP therapy
- For aCGRP-IR group: failed at least one aCGRP preventive treatment
- Ability to distinguish migraine headaches from tension-type headaches
- Female participants must not be pregnant, breastfeeding, or planning pregnancy, and must use effective contraception if of childbearing potential
- Agreement to avoid egg donation and in vitro fertilisation during the study and for 10 weeks after last dose
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 allergies or hypersensitivity to immunisations or immunoglobulins
- Significant psychiatric disorders affecting safety or data integrity
- Significant illnesses including cardiovascular, neurological (other than migraine), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine diseases
- History of cancer within 5 years before screening except certain non-progressive skin, cervical, or prostate cancers
- Drug or alcohol abuse within 1 year before screening or positive tests at screening
- History of certain heart rhythm problems or QT prolongation
- Use of migraine preventive medications within 30 days before screening and during the study
- Prior aCGRP therapy use for aCGRP-Naive group
- Frequent use of opioids or barbiturates for pain within 6 months before screening
- Use of botulinum toxin for migraine or cosmetic reasons in head, face, or neck within 4 months before screening
- Use of migraine interventions or devices within 2 months before screening
- Use of certain drugs or supplements within 7 days before screening unless stable and safe
- Need for other biological treatments during the study
- Recent participation in other clinical trials with investigational products
- Known allergy to MEDI0618 or its components
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive subcutaneous MEDI0618 or placebo to prevent migraine headaches.
Visits on Day 1, Day 29, Day 57, and Day 85
Duration - Up to 8 weeks after treatment
Participants are monitored for safety and efficacy after the treatment period ends.
Visits up to Day 141
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
Actively Recruiting
20
Axon Clinical s.r.o.
Prague, Czechia, 150 00
Actively Recruiting
21
Praglandia s.r.o.
Prague, Czechia, 150 00
Actively Recruiting
22
Forbeli s.r.o
Prague, Czechia, 160 00
Actively Recruiting
23
Institut Neuropsychiatricke Pece (INEP)
Prague, Czechia, 186 00
Actively Recruiting
24
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia, 266 55
Actively 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
Actively 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
Actively Recruiting
33
S-Medicon Kft.
Budapest, Hungary, 1138
Actively 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
Actively Recruiting
40
Centrum Medyczne Pratia - Katowice
Katowice, Poland, 40-081
Actively Recruiting
41
Specjalistyczne Gabinety Sp. z o.o.
Krakow, Poland, 30-539
Actively Recruiting
42
FutureMeds Sp. z.o.o.
Krakow, Poland, 31-501
Actively 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
Actively Recruiting
46
FutureMeds Warszawa Centrum
Warsaw, Poland, 00-215
Actively Recruiting
47
MTZ Clinical Research Sp. z o.o.
Warsaw, Poland, 02-172
Actively 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
Actively Recruiting
52
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
53
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
54
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
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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