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

NCT06602479 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: D7060C00003IND 1701452024-512904-21
• Study Type: interventional
• Target: 488
• Locations: 8 countries
• Sites: 54

Brief 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.

Conditions

Migraine

Keywords

MEDI0618; Episodic Migraine; Migraine headache day(s) - MHD

Outcome Measures

Primary Outcomes (1)

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

  Change in number of MHDs from 4-week baseline to last 4 weeks of treatment period.

  Week 9 to Week 12

Secondary Outcomes (6)

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

  Week 9 to Week 12

• Effect of repeat doses of MEDI0618 on disability caused by migraine headaches

  Day 1 to Day 85 and to Day 141

• Effect of repeat doses of MEDI0618 on disability caused by migraine headaches

  Day 1, Day 29, Day 57 and Day 85 and to Day 141

• Effect of repeat doses of MEDI0618 on the severity of migraine headaches

  Week 9 to Week 12

• Effect of repeat doses of MEDI0618 on the severity of migraine headaches

  Week 9 to Week 12

Study Arms (7)

aCGRP-N_MEDI0618 (Dose A)

EXPERIMENTAL

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.

Drug: MEDI0618

aCGRP-N_Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

aCGRP-N_MEDI0618 (Dose B)

EXPERIMENTAL

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.

Drug: MEDI0618

aCGRP-N_MEDI0618 (Dose C)

EXPERIMENTAL

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.

Drug: MEDI0618

aCGRP-N_MEDI0618 (Dose D)

EXPERIMENTAL

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.

Drug: MEDI0618

aCGRP-IR_MEDI0618 (Dose A)

EXPERIMENTAL

In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).

Drug: MEDI0618

aCGRP-IR_Placebo

PLACEBO COMPARATOR

In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).

Drug: Placebo

Interventions

MEDI0618 DRUG

MEDI0618 per protocol

aCGRP-IR_MEDI0618 (Dose A); aCGRP-N_MEDI0618 (Dose A); aCGRP-N_MEDI0618 (Dose B); aCGRP-N_MEDI0618 (Dose C); aCGRP-N_MEDI0618 (Dose D)

Placebo DRUG

Volume-matched placebo for all arms

aCGRP-IR_Placebo; aCGRP-N_Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

Flourish - Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Tennessee Valley Neurological Associates PC

Huntsville, Alabama, 35801, United States

WITHDRAWN

The Neurology Center of Southern California - Carlsbad Office

La Jolla, California, 92037, United States

RECRUITING

Clinical Research Institute, LCC

Los Angeles, California, 90048, United States

RECRUITING

Homestead Associates in Research, Inc.

Homestead, Florida, 33033, United States

NOT YET RECRUITING

Florida Neurology - Lake Mary

Lake Mary, Florida, 32746, United States

NOT YET RECRUITING

Flourish Research - Miami, LLC dba Flourish Research

Miami, Florida, 33135, United States

RECRUITING

BayCare Medical Group Neurology at St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

NOT YET RECRUITING

Santos Research Center, Corp - Tampa

Tampa, Florida, 33615, United States

RECRUITING

Norton Neuroscience Institute - Headache Clinic

Louisville, Kentucky, 40207, United States

WITHDRAWN

Modern Migraine, MD

New York, New York, 10001, United States

WITHDRAWN

Velocity Clinical Research, Providence (East Greenwich)

East Greenwich, Rhode Island, 02818, United States

NOT YET RECRUITING

Palmetto Primary Care Physicians Division of Gastroenterology - Summerville

Summerville, South Carolina, 29486, United States

RECRUITING

FutureSearch Trials

Austin, Texas, 78731, United States

RECRUITING

Vaught Neurological Services, PLLC

Crab Orchard, West Virginia, 25827, United States

NOT YET RECRUITING

The Mind+ Neurology Clinic

Mequon, Wisconsin, 53092, United States

RECRUITING

Brain-Soultherapy s.r.o.

Kladno, 272 01, Czechia

NOT YET RECRUITING

Clintrial s.r.o.

Prague, 100 00, Czechia

NOT YET RECRUITING

DADO Medical s.r.o.

Prague, 120 00, Czechia

RECRUITING

Axon Clinical s.r.o.

Prague, 150 00, Czechia

RECRUITING

Praglandia s.r.o.

Prague, 150 00, Czechia

RECRUITING

Forbeli s.r.o

Prague, 160 00, Czechia

RECRUITING

Institut Neuropsychiatricke Pece (INEP)

Prague, 186 00, Czechia

RECRUITING

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, 266 55, Czechia

RECRUITING

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

Glostrup Municipality, 2600, Denmark

NOT YET RECRUITING

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

Berlin, 10117, Germany

NOT YET RECRUITING

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, 09111, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

NOT YET RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

NOT YET RECRUITING

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, 65929, Germany

NOT YET RECRUITING

Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz

Westerstede, 26655, Germany

NOT YET RECRUITING

Óbudai Egészségügyi Centrum

Budapest, 1036, Hungary

RECRUITING

S-Medicon Kft.

Budapest, 1138, Hungary

RECRUITING

Obudai Egeszsegugyi Centrum - Dunaujvaros

Dunaújváros, 2400, Hungary

NOT YET RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

NOT YET RECRUITING

IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Pavia, 27100, Italy

NOT YET RECRUITING

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

NOT YET RECRUITING

IRCCS San Raffaele Pisana

Roma, 00163, Italy

NOT YET RECRUITING

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, 85-796, Poland

RECRUITING

Centrum Medyczne Pratia - Katowice

Katowice, 40-081, Poland

RECRUITING

Specjalistyczne Gabinety Sp. z o.o.

Krakow, 30-539, Poland

RECRUITING

FutureMeds Sp. z.o.o.

Krakow, 31-501, Poland

RECRUITING

Centrum Medyczne Hope Clinic

Lublin, 20-701, Poland

NOT YET RECRUITING

Solumed Centrum Medyczne

Poznan, 60-529, Poland

NOT YET RECRUITING

Centrum Medyczne HCP Sp. z o.o.

Poznan, 61-485, Poland

RECRUITING

FutureMeds Warszawa Centrum

Warsaw, 00-215, Poland

RECRUITING

MTZ Clinical Research Sp. z o.o.

Warsaw, 02-172, Poland

RECRUITING

European Trial Group (ETG) - Warszawa

Warsaw, 02-677, Poland

RECRUITING

Hospital Universitario de Badajoz

Badajoz, 06080, Spain

NOT YET RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

NOT YET RECRUITING

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

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will be performed in a double-blind manner (ie, investigator and participant blind). The responsible personnel preparing IP at the site will have access to participants' unblinded treatment assignments. The IRT/RTSM will provide to the investigators or pharmacists the kit identification numbers to be allocated to the participant at the dispensing visit.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is parallel-group, participant and investigator blinded, treatment study. 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.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): May 7, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CZ (8); IT (4); HU (3); US (16); PL (10); DE (6); DK (1); ES (6)