RecruitingPHASE3INTERVENTIONAL

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

This research study is looking into a medicine called eptinezumab for teenagers (12-17 years old) who suffer from chronic migraines. Chronic migraine means having headaches very often. The main goal is to find out if eptinezumab is better at lowering the number of days young people have migraines compared to a 'placebo' (a dummy treatment that looks like the real medicine but has no active ingredients). This is a Phase 3 study, which means it’s one of the final steps before a medicine might be approved. Participants will receive a single dose of either the study medicine or the placebo through a drip. Doctors will then observe them for several weeks to see how they respond.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

H. Lundbeck A/S

Enrolment target

285

Start

30 Jun 2021

Estimated completion

31 Oct 2026

Chronic Migraine in Children

What is this study about?

Many young people struggle with chronic migraines, which means they have frequent and often severe headaches that can make daily life very difficult. This study is exploring a new treatment option called eptinezumab to see if it can help reduce how often these debilitating headaches occur. Researchers want to compare eptinezumab to a 'placebo', which is a harmless liquid, to understand if the medicine itself is making a difference.

Finding new ways to manage chronic migraines in young people is really important. If this medicine is shown to be effective, it could offer a new hope for teenagers who are currently living with frequent migraine attacks. The study follows a careful design to ensure the results are reliable and that participants' safety is a top priority, without making any medical recommendations.

This research is a 'Phase 3' study, which means it's a large-scale evaluation after earlier tests have shown promising results. The information gathered from studies like this helps doctors and medical authorities decide if a new treatment is safe and effective enough to be used more widely.

Key takeaways

This study is for 12-17 year olds with chronic migraines.
It tests a new migraine medicine called eptinezumab against a dummy treatment (placebo).
The goal is to reduce the number of migraine days.
Treatment is a single dose given through a drip.
The study lasts about 24 weeks and involves careful monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be between 12 and 17 years old and have been diagnosed with chronic migraine for at least six months. This means you have specific patterns of headaches, including a certain number of headache days each month, with at least some being migraine days, as recorded in a special headache diary.

There are also some reasons why you might not be able to join. For example, if you've already been part of this specific study before, or if you've recently had other treatments that are similar to the study medicine, you wouldn't be able to participate. Also, if you have certain other specific types of headaches or very unusual migraine symptoms, the study might not be right for you.

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 12 and 17 years old?
Have you been diagnosed with chronic migraine for at least 6 months?
Do you have headaches on 15 or more days a month, with at least 8 of those being migraines?
Have you not received any similar antibody treatments for migraines in the last 6 months?
Do you not have other specific types of headaches or very unusual migraine symptoms?
Are you able to accurately complete a headache diary for most days?

Answer every question to see your result.

What does participation involve?

If you join the study, it will last for about 24 weeks, which is roughly five and a half months. It starts with a four-week period where doctors will check if you meet all the requirements. During this time, you'll need to accurately fill out an electronic headache diary for most days.

If you are eligible, you'll have a main visit where you receive a single dose of the study medicine or the placebo. This will be given through a drip into your arm (intravenous infusion). You won't know if you're getting the active medicine or the placebo, and neither will the study doctors – this helps make the results fair. After this, you'll be monitored closely for 12 weeks to see how your migraines change. Following this, there will be an eight-week safety follow-up period where your health will continue to be checked. Your dosage of the medicine will be adjusted based on your body weight.

Potential risks and benefits

Participating in a clinical study can have potential benefits, such as gaining access to a new treatment that might help your migraines before it's widely available. However, there are also potential risks, as with any new medicine, including possible side effects that aren't yet fully known. The placebo group won't receive the active medicine, so they won't experience its effects, positive or negative. You would be closely monitored throughout the study for any health changes. It's very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (84)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Yale-New Haven Children's Hospital - PIN
Verified postcode
New Haven, United States· Recruiting
Ki Health Partners LLC DBA New England Institute for Clinical Research
Verified postcode
Stamford, United States· Recruiting
Children's National Medical Center
Verified postcode
Washington D.C., United States· Completed
NW FL Clinical Research Group, LLC
Verified postcode
Gulf Breeze, United States· Recruiting
AGA Clinical Trials - Hialeah - 4980 W 10th Ave
Verified postcode
Hialeah, United States· Recruiting
Axcess Medical Research
Verified postcode
Loxahatchee Groves, United States· Completed
University of South Florida
Verified postcode
Tampa, United States· Recruiting
Clinical Integrative Research Center of Atlanta
Verified postcode
Atlanta, United States· Recruiting
University of Kentucky HealthCare (UKHC) Kentucky Clinic
Verified postcode
Lexington, United States· Recruiting
University of Maryland
Verified postcode
Baltimore, United States· Recruiting
Michigan Head Pain and Neurological Institute
Verified postcode
Ann Arbor, United States· Completed
Michigan State University - Department of Neurology
Verified postcode
East Lansing, United States· Completed

Common questions

What is eptinezumab?

Eptinezumab is a new medicine being tested to see if it can help reduce the number of migraine days in young people with chronic migraine.

What is a 'placebo'?

A placebo is a dummy treatment, often a sterile salt water solution, that looks and is given just like the actual medicine but contains no active ingredients. It helps researchers see if the real medicine is truly effective.

How will I receive the treatment?

The medicine or placebo will be given to you through a drip into your arm, which is called an intravenous (IV) infusion.

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

No, you won't know, and neither will the study doctors. This is a common method in clinical trials to ensure the results are fair and unbiased.

How long does the study last?

The entire study will last for about 24 weeks, which includes screening, treatment, and follow-up periods.

How to find out more

Email contact via H. Lundbeck A/S

hq_medinfo@lundbeck.com +45 36301311 Official trial record

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