New shot aims to cut migraine days in half

NCT ID NCT06602479

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether a new drug called MEDI0618 can safely reduce the number of migraine headache days in adults with episodic migraine. About 488 participants will receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug lowers migraine days compared to no treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: MEDI0618 (a drug given as a shot under the skin)
What this could lead to: If it works, this could provide a new option to prevent migraine headaches and reduce the number of migraine days per month.
What could go wrong: This is an early Phase 2 trial, so it may not show a clear benefit over placebo. Side effects are still being studied, and the drug may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 488 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 to 70 years of age * Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2. * History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening. * At least 12 MHDs over the last 3 months prior to screening. * Participants must fulfil the following criteria for migraine in prospectively collected baseline information during the 4 consecutive weeks of baseline migraine headache data collection prior to Day 1: (a) ≥ 4 and ≤ 14 MHDs per month. (b) On ≥ 4 days, fulfils any of the following criteria: (i) migraine without aura; (ii) migraine with an aura symptom accompanied or followed by a headache within 60 minutes; (iii) probable migraine; (iv) recurrent attacks that do not match ICHD criteria for migraine but successfully respond to migraine-specific medication. * Participants who fulfil criteria for MOH are eligible for this study. * History of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes (a) aCGRP-N participants are eligible to receive an aCGRP therapy but must have not yet received aCGRP therapy for acute or preventive treatment at any time. (b) aCGRP-IR participants must have tried and have failed at least one aCGRP therapy used for preventive treatment. * Participants must be able to distinguish migraine headaches from tension-type headaches. * Female participants who are not pregnant and do not plan to become pregnant during the study, are not lactating, or are of nonchildbearing potential. FOCBP who are sexually active with a non-sterilised male partner must use adequate contraception consisting of two highly effective methods of contraception throughout the study. FOCBP must agree to comply with protocol specified guidance for safe administration of MEDI0618. FOCBP must refrain from egg donation and in vitro fertilisation from the time of signing the ICF, throughout the study, and for 10 weeks after the last administration of investigational product (IP). Exclusion Criteria: * History of migraine sub-types including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine * History of headache other than migraine within 3 months prior to screening. * History of severe or ongoing allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins. * History of any significant psychiatric disorder which could be detrimental to participant safety or could compromise study data interpretation. * Presence of any clinically significant illness, such as cardiovascular, neurologic (except for non-exclusionary headaches in participants with migraine), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder. * History of cancer within 5 years of screening, or between screening and randomisation, with the exception of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix, or non-progressive prostate cancer. * Known history of drug or alcohol abuse within 1 year of screening or positive test for drugs of abuse or alcohol at screening or at Day -1. * History of QT prolongation \> 450 msec (\> 470 msec for participants aged ≥ 65 years) associated with other medications that required discontinuation of that medication. * Congenital long or short QT syndrome. * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted. * Use of migraine preventive medications within 30 days or 5 half-lives (whichever is longer) prior to screening and throughout the study * For aCGRP-N participants only: prior use of an aCGRP therapy for acute or preventive treatment. * Use of opioids or barbiturate containing analgesic \> 2 times/month on average in the 6 months prior to screening for the treatment of pain (opioid administration in an emergency setting may be an exception). * Use of botulinum toxin (e.g., Botox ®, Dysport®, Jeuveau™, Myobloc®, Xeomin®) for migraine or for any other medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months prior to screening. * Use of an intervention or device (eg, scheduled nerve block, transcranial magnetic stimulation) for treatment of migraine within 2 months of screening. * Use of prescription or non-prescription, non-biologic drugs, including vitamins and herbal and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to screening and throughout the study unless the medication will not interfere with the study procedures or compromise participant safety; the dose and regimen must have been stable for at least 3 months prior to screening and must remain stable throughout the study. * Requires treatment with another biological therapeutic agent including IV immunoglobulin treatment during the course of the study. Prior use of therapeutic antibodies is allowed if that use was \> 5 half-lives of the intervention or 3 months prior to screening, whichever is longer. * Therapeutic vaccines are permitted during the study, but ideally, live attenuated vaccines should be administered \> 30 days prior to randomisation and inactivated vaccinations (eg, inactive influenza, COVID-19) should be administered \> 14 days prior to randomisation. * Participation in another clinical study with an IP, including an experimental vaccine, or device, within 5 half-lives of the intervention or 3 months prior to screening, whichever is longer. * Known hypersensitivity to MEDI0618 or any of the excipients of the product. Other protocol defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

51 sites in 8 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Axon Clinical s.r.o.
RECRUITING

Prague, 150 00, Czechia
BayCare Medical Group Neurology at St. Anthony's Hospital
NOT_YET_RECRUITING

St. Petersburg, Florida, 33705, United States
Brain-Soultherapy s.r.o.
NOT_YET_RECRUITING

Kladno, 272 01, Czechia
Centrum Medyczne HCP Sp. z o.o.
RECRUITING

Poznan, 61-485, Poland
Centrum Medyczne Hope Clinic
NOT_YET_RECRUITING

Lublin, 20-701, Poland
Centrum Medyczne Pratia - Katowice
RECRUITING

Katowice, 40-081, Poland
Centrum Medyczne Pratia Bydgoszcz
RECRUITING

Bydgoszcz, 85-796, Poland
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Neurologie
NOT_YET_RECRUITING

Berlin, 10117, Germany
Clinical Research Institute, LCC
RECRUITING

Los Angeles, California, 90048, United States
Clintrial s.r.o.
NOT_YET_RECRUITING

Prague, 100 00, Czechia
DADO Medical s.r.o.
RECRUITING

Prague, 120 00, Czechia
European Trial Group (ETG) - Warszawa
RECRUITING

Warsaw, 02-677, Poland
Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz
NOT_YET_RECRUITING

Westerstede, 26655, Germany
Florida Neurology - Lake Mary
NOT_YET_RECRUITING

Lake Mary, Florida, 32746, United States
Flourish - Birmingham
RECRUITING

Birmingham, Alabama, 35205, United States
Flourish Research - Miami, LLC dba Flourish Research
RECRUITING

Miami, Florida, 33135, United States
Forbeli s.r.o
RECRUITING

Prague, 160 00, Czechia
FutureMeds Sp. z.o.o.
RECRUITING

Krakow, 31-501, Poland
FutureMeds Warszawa Centrum
RECRUITING

Warsaw, 00-215, Poland
FutureSearch Trials
RECRUITING

Austin, Texas, 78731, United States
Homestead Associates in Research, Inc.
NOT_YET_RECRUITING

Homestead, Florida, 33033, United States
Hospital Clinico Universitario de Valencia
RECRUITING

Valencia, 46010, Spain
Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
RECRUITING

Barcelona, 08035, Spain
Hospital Universitari i Politècnic La Fe
RECRUITING

Valencia, 46026, Spain
Hospital Universitario La Paz
RECRUITING

Madrid, 28046, Spain
Hospital Universitario de Badajoz
NOT_YET_RECRUITING

Badajoz, 06080, Spain
Hospital del Mar
NOT_YET_RECRUITING

Barcelona, 08003, Spain
IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino
NOT_YET_RECRUITING

Pavia, 27100, Italy
IRCCS Ospedale San Raffaele
NOT_YET_RECRUITING

Milan, 20132, Italy
IRCCS San Raffaele Pisana
NOT_YET_RECRUITING

Roma, 00163, Italy
Institut Neuropsychiatricke Pece (INEP)
RECRUITING

Prague, 186 00, Czechia
Kopfschmerzzentrum Frankfurt
NOT_YET_RECRUITING

Frankfurt am Main, 65929, Germany
MTZ Clinical Research Sp. z o.o.
RECRUITING

Warsaw, 02-172, Poland
Modern Migraine, MD
WITHDRAWN

New York, New York, 10001, United States
Norton Neuroscience Institute - Headache Clinic
WITHDRAWN

Louisville, Kentucky, 40207, United States
Obudai Egeszsegugyi Centrum - Dunaujvaros
NOT_YET_RECRUITING

Dunaújváros, 2400, Hungary
Palmetto Primary Care Physicians Division of Gastroenterology - Summerville
RECRUITING

Summerville, South Carolina, 29486, United States
Pharmakologisches Studienzentrum Chemnitz GmbH
RECRUITING

Chemnitz, 09111, Germany
Policlinico Universitario Campus Bio-Medico
NOT_YET_RECRUITING

Roma, 00128, Italy
Praglandia s.r.o.
RECRUITING

Prague, 150 00, Czechia
Rigshospitalet (Copenhagen University Hospital) - Dansk Hovedpinecenter (Danish Headache Center)
NOT_YET_RECRUITING

Glostrup Municipality, 2600, Denmark
S-Medicon Kft.
RECRUITING

Budapest, 1138, Hungary
Santos Research Center, Corp - Tampa
RECRUITING

Tampa, Florida, 33615, United States
Solumed Centrum Medyczne
NOT_YET_RECRUITING

Poznan, 60-529, Poland
Specjalistyczne Gabinety Sp. z o.o.
RECRUITING

Krakow, 30-539, Poland
Tennessee Valley Neurological Associates PC
WITHDRAWN

Huntsville, Alabama, 35801, United States
The Mind+ Neurology Clinic
RECRUITING

Mequon, Wisconsin, 53092, United States
The Neurology Center of Southern California - Carlsbad Office
RECRUITING

La Jolla, California, 92037, United States
Universitätsklinikum Carl Gustav Carus Dresden
NOT_YET_RECRUITING

Dresden, 01307, Germany
Universitätsklinikum Essen
NOT_YET_RECRUITING

Essen, 45147, Germany
Vaught Neurological Services, PLLC
NOT_YET_RECRUITING

Crab Orchard, West Virginia, 25827, United States
Velocity Clinical Research, Providence (East Greenwich)
NOT_YET_RECRUITING

East Greenwich, Rhode Island, 02818, United States
Vestra Clinics s.r.o.
RECRUITING

Rychnov nad Kněžnou, 266 55, Czechia
Óbudai Egészségügyi Centrum
RECRUITING

Budapest, 1036, Hungary

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