RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe MEDI0618 is and how well it works for adults ages 18 to 70 with migraines on some days each month. MEDI0618 is given as a shot under the skin and compared with a placebo, a shot with no active study drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 70 years old, weigh at least 40 kg (about 88 pounds), and have a BMI of at least 18. BMI is a measure based on height and weight.
  • Have had migraines for at least 12 months, starting at age 50 or younger. Migraines may be with or without aura, such as changes in vision.
  • Have had at least 12 migraine headache days in the 3 months before screening.
  • During the 4-week tracking period, have 4 to 14 migraine headache days. At least 4 days must meet the study’s headache rules, which include certain headaches that respond to migraine medicine.
  • Have tried at least 2 small-molecule migraine prevention drugs from different drug groups without success. For aCGRP drugs, which block a migraine-related protein, you must either be eligible but never have used them, or have tried at least one for prevention without success.
  • Be able to tell migraines apart from tension headaches. Headaches from using too much headache medicine are allowed.
  • For women: not be pregnant, planning pregnancy during the study, or breastfeeding. If you can become pregnant and have sex with a male partner who has not been sterilized, use 2 highly effective birth control methods and follow the study’s safety rules.
  • If you can become pregnant, avoid egg donation and in vitro fertilization from signing consent until 10 weeks after the last study dose.

Who can't join

  • Have certain migraine types involving muscle weakness, eye muscle problems, or the brainstem; or have a history of headaches other than migraine in the past 3 months.
  • Have severe or ongoing allergic reactions, past reactions to vaccines or immune-protein treatments, or an allergy to MEDI0618 or its ingredients.
  • Have a serious mental health condition that could affect safety or study results, or another major illness. Most cancers within 5 years are excluded, but certain skin, cervical, and prostate cancers are allowed.
  • Have drug or alcohol abuse within the past year, or a positive drug or alcohol test at screening or the day before treatment.
  • Have certain heart rhythm problems, including inherited long or short QT syndrome, which affects the heart’s electrical timing. Some past drug-related QT changes also exclude you. Atrial fibrillation controlled with medicine is allowed.
  • Use migraine prevention medicine during the study or too close to screening: within 30 days or longer for drugs that stay in the body longer. Other drugs, vitamins, and supplements also have limits unless approved under the study rules.
  • Use opioid or barbiturate pain medicines more than twice a month on average in the past 6 months, with a possible emergency-care exception; have head, face, or neck botulinum toxin shots within 4 months; or use a migraine treatment device or procedure within 2 months.
  • Need another biologic treatment, such as an antibody medicine, during the study; have used certain antibody treatments too recently; or have recently joined another study testing a drug, vaccine, or device. Required waiting times vary. Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (16)

AL

CA

FL

KY

NY

RI

SC

TX

WI

WV