RecruitingPHASE3INTERVENTIONAL

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

This research is an important next step for children and teenagers aged 6 to 17 who experience migraine headaches and have already been involved in an earlier study looking at a medication called eptinezumab. The main aim is to carefully check the long-term safety of eptinezumab when used by young people. Participants will continue to receive the study medication, with different groups receiving either a 100 mg or 300 mg dose, adjusted for their weight. Those who previously received a dummy treatment (placebo) will now be given one of the active doses. This study will help doctors understand how safe this treatment is over a longer period for young people with migraine.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

H. Lundbeck A/S

Enrolment target

600

Start

01 Dec 2021

Estimated completion

30 Apr 2028

Migraine

What is this study about?

This study is an extension of previous research, specifically for children and teenagers (aged 6 to 17) who get migraine headaches. These young people would have already taken part in an earlier study that looked at a new medication called eptinezumab for either chronic migraine (very frequent migraines) or episodic migraine (less frequent migraines).

The main purpose of this follow-up study is to keep a close eye on the long-term safety of eptinezumab. Researchers want to make sure it's safe for young people to use over a longer period. By continuing to observe participants, doctors can gather more information about any effects, good or bad, that might appear with ongoing use of the medicine.

Taking part helps doctors learn more about managing migraines in young people. This is important because migraines can significantly affect a child's life, including their schooling, friendships, and daily activities. Finding safe and effective treatments is a big step towards improving their quality of life.

Key takeaways

This study is for children and teenagers (6-17) with migraines.
It's an extension for those who were in a previous eptinezumab migraine study.
The main goal is to check the long-term safety of eptinezumab.
All participants will receive the active medication, not a placebo.
Participation involves clinic visits, infusions, and health checks.

Who may be eligible?

To join this study, you must be a child or teenager between 6 and 17 years old. Crucially, you must have already finished the first phase of an earlier study (called Study 19356A or Study 19357A) investigating eptinezumab for migraines. You would have completed all initial visits, including the one at Week 12, just before starting this new study.

There are some important reasons why you might not be able to join. If you had any health concerns or side effects during the first study that your doctor thinks could be risky for you to continue, you wouldn't be able to take part. This includes if you had a very serious allergic reaction during the previous study.

Also, if blood tests during the previous study showed certain problems with your liver, particularly if the levels of specific liver enzymes were very high or combined with high bilirubin levels, you would not be eligible for this extension study. Your doctor will carefully review your health information from the first study to make sure it's safe for you to continue.

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 6 and 17 years old?
Have you already finished an earlier migraine study (Study 19356A or 19357A) with eptinezumab?
Did you complete all your visits in that previous study, including the Week 12 visit?
Did your doctor say it's safe for you to continue with further study treatment, based on your previous study experience?
Did you avoid any severe allergic reactions or specific liver problems during the last study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the study medication, eptinezumab. If you were getting the active medication in the previous study, you'll generally continue on the same dose (either 100 mg or 300 mg, adjusted for your weight). If you received a dummy treatment (placebo) before, you'll now be randomly assigned to either the 100 mg or 300 mg dose of eptinezumab, also adjusted for your weight.

The medication is given through an infusion, which means it will be delivered directly into your vein. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and see how you are responding to the treatment. These visits will likely include physical examinations, blood tests, and discussions about your migraines and overall well-being. The total duration of this extension study will be decided by the researchers, but the aim is to look at long-term safety.

Potential risks and benefits

Participating in this study might offer the benefit of continuing to receive a potential migraine treatment that you started in the previous study. For those who were on placebo, it offers the chance to now receive the active medication. However, like all medications, eptinezumab might have side effects, and some people could experience unwanted reactions. The study team will carefully monitor you for any safety concerns throughout your participation. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (70)

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

Yale University School of Medicine
Verified postcode
New Haven, United States· Recruiting
Ki Health Partners LLC DBA New England Institute for Clinical Research
Verified postcode
Stamford, United States· Recruiting
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
University of Kentucky
Verified postcode
Lexington, United States· Recruiting
University of Maryland School of Medicine
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
Helen Devos Childrens' Hospital - PIN
Verified postcode
Grand Rapids, United States· Recruiting
Dent Neurosciences Research Center Incorporated
Verified postcode
Amherst, United States· Completed

Common questions

What is eptinezumab?

Eptinezumab is a medication being studied to help prevent migraine headaches in children and teenagers.

Who can join this study?

Children and teenagers aged 6 to 17 who have previously completed an earlier study with eptinezumab for migraines.

Will I get a dummy treatment (placebo) in this study?

No, all participants in this study will receive the active medication, eptinezumab.

How is the medication given?

The medication is given as an infusion, meaning it goes directly into a vein, usually in your arm.

Why is this study important?

It helps doctors understand the long-term safety of eptinezumab for young people with migraines and improve their treatment options.

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.