RecruitingPHASE3INTERVENTIONAL

A Study of Eptinezumab in Pediatric Participants With Episodic Migraine

This research study is investigating an experimental medicine named eptinezumab for young people between 6 and 17 years old who experience episodic migraines. Episodic migraines mean you have them on some days, but not all the time. The main aim is to discover if eptinezumab effectively lowers the number of days these young participants suffer from migraine headaches. To find this out, some participants will receive eptinezumab, while others will get a placebo (a dummy treatment with no active medicine). This comparison helps researchers understand if any improvements are genuinely due to the study medication. This type of trial is in its third phase, meaning it's one of the final steps before a medicine might be approved for wider use.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

H. Lundbeck A/S

Enrolment target

315

Start

08 Jun 2023

Estimated completion

31 Aug 2027

Episodic Migraine

What is this study about?

This study is all about helping children and teenagers who get episodic migraines. Migraines aren't just bad headaches; they can be very painful and often come with other symptoms like feeling sick or being sensitive to light and sound. When we say 'episodic migraine,' it means someone has migraines on some days, but not every day.

The researchers want to test a new medicine called eptinezumab. They're hoping it can reduce how often these young people get migraines. To do this, they'll give some participants the new medicine and others a 'placebo.' A placebo looks just like the real medicine but doesn't have any active ingredients. This helps the researchers see if eptinezumab is truly making a difference, or if improvements might happen anyway.

Finding better ways to prevent migraines in young people is really important because migraines can stop them from going to school, playing with friends, and enjoying everyday activities. This study aims to find out if eptinezumab could be a safe and effective option to give them more migraine-free days.

Key takeaways

This study is for young people (6-17) with episodic migraines.
It tests a new medicine, eptinezumab, against a dummy treatment (placebo).
The main goal is to reduce the number of migraine days.
Participation involves keeping a headache diary and clinic visits.
You might get the active drug or a placebo.
You can leave the study at any time.

Who may be eligible?

To join this study, children and teenagers must be between 6 and 17 years old and have been diagnosed with episodic migraines for at least six months. This means they get migraines sometimes, but not constantly. They will also need to keep a special diary on a device (eDiary) for most days during a screening period, which helps the doctors understand their migraine patterns. During this time, they should have had no more than 14 headache days in total, with at least 4 of those being actual migraine days.

There are also some reasons why someone might not be able to join. For example, if they have other serious types of headaches, certain brain or nervous system conditions, or an ongoing mental health condition that isn't under control. If they've had specific severe head injuries or certain rare migraine types, they also wouldn't be able to take part. The doctors leading the study will check all these details carefully to make sure the study is safe and appropriate for everyone involved.

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 been diagnosed with migraines for at least 6 months?
Do you have episodic migraines (not every day)?
Can you or your caregiver use a special electronic diary to track your headaches?
Do you not have other specific severe headache types or complex health issues?

Answer every question to see your result.

What does participation involve?

The detailed description of participation isn't fully provided in this summary, but typically, taking part in a study like this involves several visits to the clinic for check-ups and assessments. Participants would likely receive either the study medicine (eptinezumab) or the placebo. This might involve injections or infusions. They would also need to continue using the eDiary to record their migraine experiences throughout the study, helping researchers track their progress. There would be a treatment period, followed by a follow-up period to monitor their health. The total duration of participation isn't specified but usually spans several months.

Potential risks and benefits

Participating in a clinical trial like this means you might benefit from a new treatment that isn't yet widely available, and you'll receive careful medical supervision. However, there's no guarantee the treatment will work for you, and like all medicines, eptinezumab could have side effects, some of which might be unknown. There's also a chance you could receive the placebo, meaning you wouldn't get the active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (65)

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

Ki Health Partners LLC DBA New England Institute for Clinical Research
Verified postcode
Stamford, United States· Recruiting
Child Neurology of NW Florida
Verified postcode
Gulf Breeze, United States· Recruiting
AGA Clinical Trials
Verified postcode
Hialeah, United States· Recruiting
University of South Florida - 13330 USF Laurel Dr
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 School of Medicine
Verified postcode
Baltimore, United States· Recruiting
Michigan Head Pain and Neurological Institute
Verified postcode
Ann Arbor, United States· Completed
North Suffolk Neurology-Commack
Verified postcode
Commack, United States· Recruiting
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Verified postcode
Charlotte, United States· Completed
Childrens Hospital Medical Center of Akron
Verified postcode
Akron, United States· Recruiting
Cincinnati Children's Hospital Medical Center - PIN
Verified postcode
Cincinnati, United States· Recruiting

Common questions

What is episodic migraine?

Episodic migraine means you get migraine headaches on some days, but not every day. It's different from chronic (daily) migraine.

What is eptinezumab?

Eptinezumab is a new medicine being tested to see if it can help reduce the number of migraine days for people who suffer from them.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medicine but doesn't contain any active ingredients. It helps researchers see if the real medicine is truly effective.

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

No, during the study, neither you nor the study doctors will know whether you are receiving eptinezumab or the placebo. This is to ensure the results are unbiased.

How old do I need to be to join?

This study is looking for children and teenagers between the ages of 6 and 17.

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.