A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
NCT ID: NCT06602479
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
488 participants
INTERVENTIONAL
2024-10-07
2027-05-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Approximately 1220 participants will be screened to achieve 488 randomised to study intervention and 438 evaluable participants.
Study Arms:
The aCGRP-N cohort includes 5 arms (placebo and 4 active dose levels).
* A total of 160 participants will be randomised on a 1:1 basis to receive MEDI0618 or placebo.
* After 104 participants total have been randomised on a 1:1 basis to either MEDI0618 or placebo, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.
The aCGRP-IR cohort includes 2 arms (placebo and one active dose level).
* 2 arms of 80 participants each; 1 will receive MEDI0618 and 1 will receive placebo randomised on a 1:1 basis.
PREVENTION
DOUBLE
The IRT/RTSM will provide to the investigators or pharmacists the kit identification numbers to be allocated to the participant at the dispensing visit.
Study Groups
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aCGRP-N_MEDI0618 (Dose A)
In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo.
After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.
MEDI0618
MEDI0618 per protocol
aCGRP-N_Placebo
In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo.
After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.
Placebo
Volume-matched placebo for all arms
aCGRP-N_MEDI0618 (Dose B)
After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
MEDI0618
MEDI0618 per protocol
aCGRP-N_MEDI0618 (Dose C)
After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
MEDI0618
MEDI0618 per protocol
aCGRP-N_MEDI0618 (Dose D)
After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.
MEDI0618
MEDI0618 per protocol
aCGRP-IR_MEDI0618 (Dose A)
In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).
MEDI0618
MEDI0618 per protocol
aCGRP-IR_Placebo
In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).
Placebo
Volume-matched placebo for all arms
Interventions
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MEDI0618
MEDI0618 per protocol
Placebo
Volume-matched placebo for all arms
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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D7060C00003
Identifier Type: -
Identifier Source: org_study_id
IND 170145
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-512904-21
Identifier Type: OTHER
Identifier Source: secondary_id
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