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MigrainePhase 2AURORANCT06602479

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

A Phase 2 study testing MEDI0618 in people with Migraine, run by AbbVie at 71 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
What is being tested?
MEDI0618
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
309 participants
Where
71 sitesin 8 countries
Study dates
7 Oct 2024to Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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 one 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).

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

United States34 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18103

  • Dent Neurologic Institute - Amherst

    Amherst, New York, 14226

  • FutureSearch Trials

    Austin, Texas, 78731

  • Flourish - Birmingham

    Birmingham, Alabama, 35205

  • Neurology Offices of South Florida - Boca Raton

    Boca Raton, Florida, 33428

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37412

  • M3 Wake Research - Chattanooga

    Chattanooga, Tennessee, 37421

  • New York Cancer and Blood Specialists - Port Jefferson Station

    Commack, New York, 11725

  • Vaught Neurological Services, PLLC

    Crab Orchard, West Virginia, 25827

  • Future Search Trials of Dallas

    Dallas, Texas, 75251

  • Velocity Clinical Research, Providence (East Greenwich)

    East Greenwich, Rhode Island, 02818

  • Gilbert Neurology

    Gilbert, Arizona, 85297

  • Homestead Associates in Research, Inc.

    Homestead, Florida, 33033

  • Rehabilitation and Neurological Services

    Huntsville, Alabama, 35805

  • The Neurology Center of Southern California - Carlsbad Office

    La Jolla, California, 92037

  • Florida Neurology - Lake Mary

    Lake Mary, Florida, 32746

  • M3 Wake Research - Newport Beach

    Los Angeles, California, 90033

  • Clinical Research Institute, LCC

    Los Angeles, California, 90048

  • The Mind+ Neurology Clinic

    Mequon, Wisconsin, 53092

  • Flourish Research - Miami, LLC dba Flourish Research

    Miami, Florida, 33135

  • AppleMed Research Group

    Miami, Florida, 33155

  • Well Pharma Medical Research

    Miami, Florida, 33173

  • Excell Research

    Oceanside, California, 92056

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Lynn Institute of Oklahoma City

    Oklahoma City, Oklahoma, 73112

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Frontier Clinical Research - Smithfield

    Smithfield, Pennsylvania, 15478

  • BayCare Medical Group Neurology at St. Anthony's Hospital

    St. Petersburg, Florida, 33705

  • Palmetto Primary Care Physicians Division of Gastroenterology - Summerville

    Summerville, South Carolina, 29486

  • Santos Research Center, Corp - Tampa

    Tampa, Florida, 33615

  • Upstate Clinical Research Associates

    Williamsville, New York, 14221

Other trials in United States

Poland10 sites

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Centrum Medyczne Pratia - Katowice

    Katowice, 40-081

  • Specjalistyczne Gabinety Sp. z o.o.

    Krakow, 30-539

  • FutureMeds Sp. z.o.o.

    Krakow, 31-501

  • Centrum Medyczne Hope Clinic

    Lublin, 20-701

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Centrum Medyczne HCP Sp. z o.o.

    Poznan, 61-485

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215

  • MTZ Clinical Research Sp. z o.o.

    Warsaw, 02-172

  • European Trial Group (ETG) - Warszawa

    Warsaw, 02-677

Other trials in Poland

Czechia8 sites

  • Brain-Soultherapy s.r.o.

    Kladno, 272 01

  • Clintrial s.r.o.

    Prague, 100 00

  • DADO Medical s.r.o.

    Prague, 120 00

  • Axon Clinical s.r.o.

    Prague, 150 00

  • Praglandia s.r.o.

    Prague, 150 00

  • Forbeli s.r.o

    Prague, 160 00

  • Institut Neuropsychiatricke Pece (INEP)

    Prague, 186 00

  • Vestra Clinics s.r.o.

    Rychnov nad Kněžnou, 266 55

Other trials in Czechia

Spain6 sites

  • Hospital Universitario de Badajoz

    Badajoz, 06080

  • Hospital del Mar

    Barcelona, 08003

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

    Barcelona, 08035

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Germany5 sites

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

    Berlin, 10117

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Chemnitz, 09111

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Universitätsklinikum Essen

    Essen, 45147

  • Kopfschmerzzentrum Frankfurt

    Frankfurt am Main, 65929

Other trials in Germany

Italy4 sites

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

    Pavia, 27100

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • IRCCS San Raffaele Pisana

    Roma, 00163

Other trials in Italy

Hungary3 sites

  • Óbudai Egészségügyi Centrum

    Budapest, 1036

  • S-Medicon Kft.

    Budapest, 1138

  • Obudai Egeszsegugyi Centrum - Dunaujvaros

    Dunaújváros, 2400

Other trials in Hungary

Denmark1 site

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

    Glostrup Municipality, 2600

Other trials in Denmark

About this study

Official title: A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants With Episodic Migraine

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.

Read the 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 per investigator's judgement and are eligible to receive anti-calcitonin gene-related peptide (aCGRP) therapy but have not yet done so (aCGRP-naïve [aCGRP-N]); 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
Migraine
Being tested
MEDI0618, Placebo
Keywords
MEDI0618, Episodic Migraine, Migraine headache day(s) - MHD
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEDI0618Drug

    MEDI0618 per protocol

  • PlaceboDrug

    Volume-matched placebo for all arms

Study groups in NCT06602479
Study groupRoleWhat they receive
aCGRP-N_MEDI0618 (Dose A)ExperimentalIn the aCGRP-N cohort, 128 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 24 participants each.
Receives: Drug: MEDI0618
aCGRP-N_PlaceboPlacebo comparatorIn the aCGRP-N cohort, 128 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 24 participants each.
Receives: Drug: Placebo
aCGRP-N_MEDI0618 (Dose B)ExperimentalAfter 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 24 participants each on active dose arm.
Receives: Drug: MEDI0618
aCGRP-N_MEDI0618 (Dose C)ExperimentalAfter 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 24 participants each on active dose arm.
Receives: Drug: MEDI0618
aCGRP-N_MEDI0618 (Dose D)ExperimentalAfter 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 24 participants each on active dose arm.
Receives: Drug: MEDI0618
aCGRP-IR_MEDI0618 (Dose A)ExperimentalIn the aCGRP-IR cohort there will be 1:1 randomisation of participants (50 to MEDI0618 and 50 to placebo).
Receives: Drug: MEDI0618
aCGRP-IR_PlaceboPlacebo comparatorIn the aCGRP-IR cohort there will be 1:1 randomisation of participants (50 to MEDI0618 and 50 to placebo).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine

    Change from baseline in mean monthly MHDs across the 12-week treatment period.

    Measured: Up to approximately Week 12

  2. Number of Participants with Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately Day 141

Secondary outcomes (6)

  1. Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine as proportion of patients

    Participants with at least 50% reduction from baseline in number of mean monthly MHDs across the 12-week treatment period

    Measured: Up to approximately Week 12

  2. Effect of repeat doses of MEDI0618 on disability caused by migraine headaches

    Change in MIDAS score from baseline to end of treatment period and to follow-up.

    Measured: Up to approximately Day 141

  3. Effect of repeat doses of MEDI0618 on disability caused by migraine headaches

    Change in HIT-6 score from baseline throughout the treatment period and to follow-up

    Measured: Up to approximately Day 141

  4. Effect of repeat doses of MEDI0618 on the severity of migraine headaches

    Change in number of mean monthly moderate or severe MHDs from 4-week baseline across treatment period

    Measured: Up to approximately Week 12

  5. Effect of repeat doses of MEDI0618 on the severity of migraine headaches

    Change in number of mean monthly moderate or severe headache days from 4-week baseline across the 12-week treatment period

    Measured: Up to approximately Week 12

  6. Effect of repeat doses of MEDI0618 on the severity of migraine headaches

    Change in mean monthly frequency of use of permitted acute treatment to abort migraine headaches from 4-week baseline across the 12-week treatment period

    Measured: Up to approximately Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start7 Oct 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is parallel-group, participant and investigator blinded, treatment study. Approximately 550 participants will be screened to achieve 300 randomised to study intervention and 270 evaluable participants. Study Arms: The aCGRP-N cohort includes 5 arms (placebo and 4 active dose levels). * A total of 128 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 24 participants each. The aCGRP-IR cohort includes 2 arms (placebo and one active dose level). * 2 arms of 50 participants each; 1 will receive MEDI0618 and 1 will receive placebo randomised on a 1:1 basis.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602479
Sponsor's protocol ID
D7060C00003
Other IDs
IND 170145, 2024-512904-21-00
Acronym
AURORA
Status last verified
Oct 2026
First submitted
16 Sep 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEDI0618 in people with Migraine, run by AbbVie at 71 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Poland, Czechia, Spain, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine (time frame: Up to approximately Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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