Active not recruitingPHASE2INTERVENTIONAL

A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

This research study is for adults who experience regular migraines that haven't gotten better with current preventative treatments. The main goal is to figure out the most effective dose of a new drug, Lu AG09222, for preventing these headaches. Participants will be randomly assigned to receive either the new drug or a placebo (a dummy pill with no active ingredient). This helps researchers understand if and how well the new drug works. This is a "Phase 2" study, meaning it's still in the earlier stages, focusing on finding the right dose and checking for safety. If you've tried other migraine prevention medicines without success, this study might be an option for you, and it could help improve treatment options for others in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

H. Lundbeck A/S

Enrolment target

874

Start

01 Apr 2024

Estimated completion

30 Apr 2026

Migraine

What is this study about?

Migraines can be incredibly tough to live with, and for many people, finding an effective treatment can be a long and frustrating journey. This study, called a clinical trial, is looking into a new medication called Lu AG09222. The aim is to find out which dose of this medication works best to help prevent migraines in people who haven't found relief from other popular treatments. This means if you've already tried one to four different medicines to stop your migraines happening, but they haven't worked for you, this study could be relevant.

The researchers want to see if Lu AG09222 can reduce how often and how severe migraines are. Some participants will receive the active medication, while others will receive a placebo – a dummy pill that looks exactly like the study drug but contains no active ingredients. This is a common and important part of clinical trials, as it helps scientists compare the effects of the new drug against not having it, so they can be sure any changes are due to the medication itself and not just chance.

This study is currently in Phase 2, which means it's an earlier stage of research. The main focus at this stage is to identify the most effective and safest dose of Lu AG09222. By taking part, you could contribute to developing new and better ways to manage migraines for people who haven't found help from existing treatments.

Key takeaways

This study is testing a new migraine prevention drug (Lu AG09222) for adults.
It's for people whose regular migraines haven't improved with 1 to 4 other treatments.
The main goal is to find the most effective dose of the new medication.
Participants will receive either the new drug or a placebo (dummy pill).
It's a Phase 2 study, focusing on dose finding and safety.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old who has been diagnosed with migraines. You should have had migraines for at least a year and started experiencing them before you were 50. You also need to have at least four migraine days per month over the last three months.

A key part of joining is that you must have tried at least one, but no more than four, different medications to prevent your migraines in the past 10 years, and these haven't worked for you. This study is specifically for those who haven't found relief from current treatments.

There are also some things that would prevent you from taking part. For example, if you've previously received a specific type of treatment that affects a chemical called PACAP, or if you have other significant pain conditions or certain types of headaches that might confuse the study results, you might not be able to join. Your study doctor will discuss all the detailed requirements with you to make sure it's safe and appropriate for you to participate.

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 65 years old?
Have you been officially diagnosed with migraines?
Have you had at least 4 migraine days per month recently?
Have you tried 1 to 4 other migraine prevention medicines that didn't work for you?
Have you never used a PACAP-targeting migraine treatment before?
Do you have any other significant pain conditions or certain types of headaches like TMD?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the research team will explain everything thoroughly. You'll have several visits to the clinic for health checks, to receive your study medication, and for researchers to collect information about your migraines. You will be asked to keep a diary or record of your migraine days and any side effects you experience. You'll receive either the new study medication, Lu AG09222, or a placebo (a dummy pill), but you won't know which one you're getting. The study will involve regular assessments to monitor your health and how your migraines respond to the treatment. The total duration of your participation will be explained by the study team, including how long you'll be taking the medication and any follow-up appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new medication helps reduce your migraines, especially since other treatments haven't worked for you. You'll also receive careful medical monitoring throughout the study. However, like all medications, Lu AG09222 may have side effects, which the study team will discuss with you. There's also a chance you might receive the placebo and not the active drug. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (120)

Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
Verified postcode
Hoover, United States
Profound Research - Neurology Center of Southern California
Verified postcode
Carlsbad, United States
Neurology Center of North Orange County
Verified postcode
Fullerton, United States
CenExel CNS
Verified postcode
Los Alamitos, United States
ASCLEPES Research Centers
Verified postcode
Sherman Oaks, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Verified postcode
Stamford, United States
K2 Medical Research - Winter Garden
Verified postcode
Clermont, United States
Clinical Neuroscience Solutions, Inc.
Verified postcode
Jacksonville, United States
K2 Medical Research, LLC - Maitland
Verified postcode
Maitland, United States
Aqualane Clinical Research
Verified postcode
Naples, United States
K2 Medical Research Tampa LLC
Verified postcode
Tampa, United States
Premiere Research Institute Palm Beach
Verified postcode
West Palm Beach, United States

Common questions

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers compare the new drug's effects accurately.

Why is it important that I've tried other migraine medicines?

This study specifically targets people whose migraines haven't responded to existing treatments, aiming to find a new option for them.

Will I know if I'm getting the real drug or the placebo?

No, during the study, neither you nor the study team will know whether you are receiving the active drug or the placebo. This is to ensure fair and unbiased results.

How long will I be in the study?

The exact length of the study for each participant will be explained by the research team if you are eligible and interested.

What is 'Phase 2' of a clinical trial?

Phase 2 is an early stage of research where the main goals are to find the right dosage of a new medication and check its safety and how well it works.