RecruitingPHASE2INTERVENTIONAL

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

This research is looking at a new treatment called MEDI0618 for adult patients who experience regular migraines. The main goals are to find out if this new medicine is safe and if it helps reduce the number of migraine attacks, compared to a placebo, which is a treatment that looks the same but contains no active medicine. We are looking for people aged 18 to 70 who get migraines often. Some participants will have already tried and not found success with other migraine preventative medicines, including a specific type called aCGRP therapies. Others will not have tried aCGRP therapies yet. This trial is important because it could lead to new ways to help manage episodic migraines.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

488

Start

07 Oct 2024

Estimated completion

07 May 2027

Migraine

What is this study about?

This study is a Phase 2 clinical trial, which means it's an early stage of research where we test a new medicine, MEDI0618, more closely in a group of people. The main purpose is to learn if MEDI0618 can help reduce the number of migraine attacks people experience and if it's safe to use. We're comparing it to a "dummy" treatment called a placebo. A placebo looks just like the real medicine but has no active ingredients. This helps researchers understand if any improvements are genuinely due to MEDI0618 or other factors.

The study involves different groups of people. Some participants will have tried various migraine treatments before without success, including a type of therapy called aCGRP, which targets specific pathways involved in migraines. Other participants will be eligible for aCGRP therapy but haven't started it yet. By studying these different groups, researchers can get a clearer picture of how MEDI0618 might work for different people with migraines.

Understanding the safety and effectiveness of new treatments like MEDI0618 is incredibly important. If this trial shows promising results, it could eventually lead to a new option for people living with episodic migraines, potentially improving their quality of life. This research is a crucial step in developing better ways to manage this challenging condition.

Key takeaways

This study is testing a new migraine medicine called MEDI0618.
It aims to find out if MEDI0618 is safe and reduces migraine attacks compared to a placebo.
Participants must be between 18-70 years old and experience regular migraines.
You might have tried other migraine treatments that haven't worked, or be eligible for a CGRP therapy but haven't started it.
You will receive either the study medicine or a placebo, given as an injection under the skin.
You can stop participating in the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for adults between 18 and 70 years old who experience episodic migraines. You should have had migraines since before you were 50, and for at least a year. You also need to have at least 12 headache days over the last three months, with 4 to 14 migraine days each month during a four-week period before the study starts. You should be able to tell the difference between your migraines and other types of headaches, like tension headaches.

We are looking for two main groups of people. One group will have already tried at least two different types of migraine preventative medicines that didn't work for them, but they haven't tried a specific type called aCGRP therapy yet. The second group will also have tried at least two other types of preventative medicines unsuccessfully, and they will have also tried at least one aCGRP therapy that didn't work for preventing migraines.

For female participants, it's important that you are not pregnant, not planning to become pregnant during the study, and not breastfeeding. If you could become pregnant, you'll need to use two reliable forms of contraception throughout the study and for 10 weeks afterwards. You also cannot donate eggs or have IVF during this time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you get 4 to 14 migraine days per month?
Can you clearly tell the difference between your migraines and other headaches?
Have you tried at least two other preventative migraine medicines that didn't work (and possibly an aCGRP therapy that also didn't work)?
If you are a woman, are you not pregnant, not breastfeeding, and willing to use specific contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive either the new medicine, MEDI0618, or the placebo (a dummy treatment). Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study. The medicine will be given as an injection under the skin, which is known as 'subcutaneous' (SC) administration. You will have regular visits to the study clinic where the research team will monitor your health, ask about your migraines, and perform various tests to check how you're responding to the treatment and for any side effects.

You will need to keep a diary of your migraines throughout the study. The total time you'll be involved in the study will vary, but it will include an initial screening period to make sure you meet all the requirements, a treatment period where you receive the study medicine, and a follow-up period after your last dose to ensure everything is okay. All visits, tests, and medicines related to the study will be provided at no cost to you.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as gaining access to a new experimental medicine for your migraines before it's widely available, and receiving close medical monitoring from experts. However, there are also potential risks involved, including side effects from the study medicine or discomfort from injections and tests. You might also receive the placebo and not the active medicine. The research team will explain all known potential risks in detail before you decide to join. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

Flourish - Birmingham
Verified postcode
Birmingham, United States· Recruiting
Tennessee Valley Neurological Associates PC
Verified postcode
Huntsville, United States· Withdrawn
The Neurology Center of Southern California - Carlsbad Office
Verified postcode
La Jolla, United States· Recruiting
Clinical Research Institute, LCC
Verified postcode
Los Angeles, United States· Recruiting
Homestead Associates in Research, Inc.
Verified postcode
Homestead, United States· Not yet recruiting
Florida Neurology - Lake Mary
Verified postcode
Lake Mary, United States· Not yet recruiting
Flourish Research - Miami, LLC dba Flourish Research
Verified postcode
Miami, United States· Recruiting
BayCare Medical Group Neurology at St. Anthony's Hospital
Verified postcode
St. Petersburg, United States· Not yet recruiting
Santos Research Center, Corp - Tampa
Verified postcode
Tampa, United States· Recruiting
Norton Neuroscience Institute - Headache Clinic
Verified postcode
Louisville, United States· Withdrawn
Modern Migraine, MD
Verified postcode
New York, United States· Withdrawn
Velocity Clinical Research, Providence (East Greenwich)
Verified postcode
East Greenwich, United States· Not yet recruiting

Common questions

What is 'episodic migraine'?

Episodic migraine means you have migraines on a regular basis, but typically less than 15 days a month. This study is for people who get between 4 and 14 migraine days a month.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers compare the new medicine's effects accurately.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the real medicine (MEDI0618) or the placebo. This helps prevent bias.

Will I get paid to be in the study?

The study will cover all costs related to your participation, including medicine and clinic visits. You may also be reimbursed for travel expenses, but studies generally don't pay you to participate.

What happens if MEDI0618 works for me?

If MEDI0618 proves to be safe and effective in this and later studies, it might become a licensed treatment for migraines in the future. However, you will not be able to continue receiving the study drug after the trial ends.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.